Notifying FDA of Fatalities Related to 
Blood Collection or Transfusion 
 
 
Guidance for Industry 
 
 
 
 
 
 
 
 
 
 
Additional copies of this guidance are available from the Office of Communication, Outreach and 
Development (OCOD), 10903 New Hampshire, Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 
20993-0002, or by calling 1-800-835-4709 or 240-402-8010, or email ocod@fda.hhs.gov, or from 
the Internet at https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-
information-biologics/biologics-guidances. 
 
For questions on the content of this guidance, contact OCOD at the phone numbers or email 
address listed above. 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Biologics Evaluation and Research 
September 2003 
Updated August 2021 
  Notifying FDA of Fatalities Related to 
Blood Collection or Transfusion 
 
 
Guidance for Industry 
 
 
 
Note:  Changes have been made to update the guidance of the same title dated September 2003, 
including:  
 
  Revised sections III and VI to update the contact information for how to notify FDA or 
make inquiries of FDA.  
  Other minor editorial or format changes.  Contains Nonbinding Recommendations 
 
 
Table of Contents 
 
 
 
I.  PURPOSE ................................................................................................................ 1 
II.  BACKGROUND ...................................................................................................... 1 
III.  HOW TO NOTIFY FDA .......................................................................................... 2 
IV.  INITIAL NOTIFICATION ...................................................................................... 2 
A.  Patient/Recipient Fatality............................................................................ 3 
B.  Donor Fatality ............................................................................................. 3 
C.  Fatality Associated with Therapeutic Apheresis or Certain Therapeutic 
Phlebotomies ............................................................................................... 3 
V.  7-DAY REPORT...................................................................................................... 4 
A.  Patient/Recipient Fatality ............................................................................. 4 
B.  Donor Fatality ............................................................................................... 5 
C.  Fatality Associated with Therapeutic Apheresis or Certain Therapeutic 
Phlebotomies ................................................................................................. 5 
VI.  INQUIRIES .............................................................................................................. 5 
 
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  Contains Nonbinding Recommendations 
 
 
Notifying FDA of Fatalities Related to Blood Collection or 
Transfusion 
 
 
Guidance for Industry 
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) on this topic.  It does not establish any rights for any person and is not binding on FDA or 
the public.  You can use an alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.  To discuss an alternative approach, contact the FDA office responsible 
for this guidance as listed on the title page. 
 
 
I.  PURPOSE 
 
This documents goal is to help you, a blood collection or transfusion facility, report fatalities 
related to blood and blood component (blood) collection or transfusion to us, the Food and Drug 
Administration (FDA), Center for Biologics Evaluation and Research (CBER).  This guidance 
updates the guidance of the same title dated September 2003. 
 
The contents of this document do not have the force and effect of law and are not meant to 
bind the public in any way, unless specifically incorporated into a contract.  This document 
is intended only to provide clarity to the public regarding existing requirements under the 
law.  FDA guidance documents, including this guidance, should be viewed only as 
recommendations, unless specific regulatory or statutory requirements are cited.  The use 
of the word should in FDA guidances means that something is suggested or recommended, 
but not required. 
 
 
II.  BACKGROUND 
 
The current good manufacturing practice (CGMP) regulations for blood and blood components 
require that you report fatalities related to blood collection or transfusion to CBER (21 CFR 
606.170(b)).  Section 606.170(b) states: 
 
When a complication of blood collection or transfusion is confirmed to be fatal, the 
Director, Office of Compliance and Biologics Quality, CBER, must be notified by 
telephone, facsimile, express mail, or electronically transmitted mail as soon as 
possible.  A written report of the investigation must be submitted to the Director, 
Office of Compliance and Biologics Quality, CBER, by mail, facsimile, or 
electronically transmitted mail (for mailing address, see  600.2(a) of this chapter), 
within 7 days after the fatality by the collecting facility in the event of a donor 
reaction, or by the facility that performed the compatibility tests in the event of a 
transfusion reaction.  (Emphasis added) 
 
 
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  Contains Nonbinding Recommendations 
 
 
Standard operating procedures for compatibility testing are required in 21 CFR 606.151 and 
606.100(b)(8).  Among other things, that regulation requires an establishment to have procedures 
both for collecting and identifying the blood samples of recipients, and for demonstrating 
incompatibility between the donors cell type and the recipients serum or plasma type.  CBER is 
aware that some blood banks and transfusion services may enter into contracts with blood centers or 
other blood banks or clinical laboratories to perform testing on blood samples.  If this is how your 
facility operates, the responsibility for compatibility testing is shared between the blood bank or 
transfusion service that collects and identifies the blood sample of the recipient, and the blood 
center or other blood bank or clinical laboratory that uses procedures to demonstrate 
incompatibility between the donated blood product and the recipient.  If a transfusion-related 
fatality occurs, both the transfusing facility and the blood center or bank that performed the testing 
under contract would be responsible for reporting the death to CBER.  Under these circumstances, 
the two facilities may make a joint report under 21 CFR 606.170(b). 
 
 
III.  HOW TO NOTIFY FDA 
 
Section 606.170(b) states that you may report a fatality by telephone, facsimile, express mail, or 
electronically transmitted mail (email).  We recommend that you submit the initial notification by 
email, if possible, and if you do so, you will receive an email confirmation receipt from us.  If 
email is not feasible, please notify us by telephone or facsimile.  We cannot access notification 
outside of customary working hours unless you use email or telephone.  Similarly, we recommend 
that you submit 7-day follow up reports by email, facsimile, or express mail. 
 
  Email:  fatalities2@cber.fda.gov 
  Telephone/voice-mail number:  240-402-9160 
  Fax number:  301-837-6256, Attn:  CBER Fatality Program Manager 
  Express mail address: 
Office of Compliance and Biologics Quality/CBER 
Attn:  Fatality Program Manager  
10903 New Hampshire Ave. 
Bldg. 71, Rm. 3128 
Silver Spring, MD 20993-0002 
 
 
IV.  INITIAL NOTIFICATION 
 
There is no required FDA form or format for notifying us of fatalities related to blood transfusion 
or blood collection.  We recommend that you provide at least the following information so we can 
evaluate the potential public health significance of the event. 
 
  Date and time of the notification. 
  Your name, title, telephone number with area code, and fax number (if available). 
  Your facility's name, mailing address, and FDA registration number (if applicable). 
NOTE:  Transfusion services that do not routinely collect or process blood or blood 
components are not required to register with FDA and, therefore, do not usually have a 
registration number. 
  Age and sex of the deceased. 
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  Contains Nonbinding Recommendations 
 
 
  Date, time, and cause or suspected cause of death (briefly describe what happened). 
  If an autopsy was or will be performed. 
  Name and address of facility where the fatality occurred if different from your facility. 
  Please also include in the initial notification the information listed in A, B, or C below, 
as appropriate: 
 
A.  Patient/Recipient Fatality 
  Transfusion date(s), 
  Blood/blood component(s) and unit number(s) of product(s) that may be 
implicated, 
  Name and address of facility(ies) providing the blood, and 
  Brief description of events that led to the fatality  include underlying 
medical condition or disease and circumstances necessitating this 
hospitalization, reason for transfusion, how the patient initially responded to 
the transfusion, any medical intervention taken or response to the reaction, 
and time from initiating the transfusion to patients death. 
 
B.  Donor Fatality 
  Collection date, 
  What product was collected or attempted to be collected, 
  Whether this was a manual or automated collection, 
  If automated, the name and model of collection device and device 
manufacturer, and 
  Brief description of events that led to the fatality  include an overview of 
the donors previous donations/health history, approximate frequency of 
donation, any unusual events that occurred during this or any previous 
donation by the donor, any medical intervention taken or response to the 
reaction, and time from initiating the blood collection to donors death. 
 
C.  Fatality Associated with Therapeutic Apheresis or Certain 
Therapeutic Phlebotomies 
  Date of therapeutic apheresis (e.g., therapeutic plasma exchange) or 
therapeutic phlebotomy, 
NOTE:  A report is required for a therapeutic apheresis fatality only if blood 
products (e.g., plasma, albumin), rather than products such as crystalloids or 
hydroxyethyl starch, were given as part of the procedure.  A report is 
required for a therapeutic phlebotomy fatality only if a blood product was 
collected for manufacture into transfusable biologics. 
  Whether product was collected, and the products disposition, 
  Whether this was a manual or automated collection (if automated, include 
manufacturer, name, and model of collection device), 
  If any blood product(s) was transfused, identify the product and the unit or 
lot number(s), and 
  Brief description of events that led to the fatality  include underlying 
medical condition or disease and circumstances necessitating the therapeutic 
apheresis or therapeutic phlebotomy, any medical intervention or response 
to the reaction, and time from initiating the procedure to patients death. 
 
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  Contains Nonbinding Recommendations 
 
 
 
V.  7-DAY REPORT 
 
You must submit a written report of the fatality investigation to CBER within 7 days after the 
fatality (21 CFR 606.170(b)).  We recommend that you identify this report as a follow-up on a 
fatality notification previously reported to CBER and include the initial notification date.  We also 
recommend that this 7-day report provide any new findings or information relevant to the fatality 
that have become available since the initial notification, including your follow-up investigation 
and conclusions. 
 
Section 606.170(a) requires that you conduct a thorough investigation of adverse reactions 
relating to blood collection or transfusion.  Section 606.170(b) requires submission of a written 
report of such investigation within 7 days after an adverse reaction resulting in fatality.  We 
recommend that a thorough investigation, and an associated written report for a fatality, include: 
  Discharge summary and/or death certificate, 
  Autopsy report (if performed), 
  Conclusions and follow-up actions (frequently referred to in the blood community as a 
corrective action plan), if appropriate, and 
  Either A, B, or C listed below, as appropriate. 
 
We understand that, due to the complexity of some fatality investigations, some of this information 
may not be available when you submit your 7-day report.  In that event, you may amend your 7-
day report by filing additional information as it becomes available. 
 
A.  Patient/Recipient Fatality 
  Complete transfusion reaction report, including the manufacturer and lot 
number of the blood collection system and results of the clerical, serological, 
and visual re-checks performed. 
  Additional relevant documents include hematology reports; clinical chemistry 
reports for cardiac and/or liver enzymes, albumin, and bilirubin; viral marker 
tests; microbiology reports; reports of anti- HLA and/or anti-neutrophil 
antibody testing; tryptase levels; radiology reports; and physicians 
consults/opinions. 
  If replacement fluid(s) was given during the transfusion, indicate which fluid(s) 
and the unit or lot number(s), and include any other relevant information, 
manufacturers notices, contamination warnings, or replacement fluid recalls. 
  If responsibility for the fatality appears to be outside the blood bank, the nurses 
and/or physicians notes on the patient, radiology reports, and physicians 
consults/opinions. 
  Results of lookback investigation, including follow-up testing on implicated 
donor(s) when the fatality was the result of transfusion transmitted infectious 
disease such as hepatitis or HIV. 
  Meeting minutes or report from your transfusion committee when the fatality 
was reviewed and discussed.  If this incident was reviewed by any other 
hospital oversight group(s) such as risk management or quality practices, 
include the report or summary of their findings. 
 
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  Contains Nonbinding Recommendations 
 
 
B.  Donor Fatality 
  The deceaseds donor record file that includes the donation just before the fatal 
incident and information on all donations during the past 2 years. 
  Lot numbers and expiration dates of collection sets or harnesses; if replacement 
fluid(s) was given during the collection, indicate which fluid(s) and the unit or 
lot number(s) and include any other relevant information, such as 
manufacturers notices, contamination warnings, or replacement fluid recalls. 
  Performance log for the device and any other relevant performance logs, 
maintenance records, manufacturers notices, or recalls on significant machine 
part(s) on the device/system during the past 2 years. 
  If the donor was hospitalized due to the reaction, provide any relevant 
documents, e.g., reports of laboratory tests, which may help determine the cause 
of the fatality. 
 
C.  Fatality Associated with Therapeutic Apheresis or Certain Therapeutic 
Phlebotomies 
  A summary of the deceaseds history of previous therapeutic apheresis or 
therapeutic phlebotomy procedures, including any previous adverse reactions 
related to the procedures. 
  Lot numbers and expiration dates of collection sets or harnesses; if replacement 
fluid(s) was given at any time during the procedure, indicate which fluid(s) and 
the unit or lot number(s) and include any other relevant information, such as 
manufacturers notices, contamination warnings, or replacement fluid recalls. 
  A summary of the performance log for the device and any other relevant 
performance logs, maintenance records, and manufacturers notices or recalls 
on any significant machine part(s) on the device/system during the past 2 years. 
  If the fatality followed therapeutic plasma exchange (TPE) and Fresh Frozen 
Plasma (FFP) was the replacement fluid, an abbreviated transfusion reaction 
work-up to rule out ABO incompatibility, bacterial contamination, anaphylactic 
reaction, or WBC antibody reaction may be useful. 
 
 
VI.  INQUIRIES 
 
If you have any questions about reporting fatalities, please contact the CBER Fatality Program 
Manager at 240-402-9160. 
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