Imaging Visual Inspection Manufacturer’s Report Device Malfunction Event If a thrombus (suspected or confirmed) is associated with this device malfunction event please remember to fill out the thrombus specific section of this form. Did the patient experience a device malfunction (failure of one or more of the components of the MCSD system which either directly causes or could potentially induce a state of inadequate circulatory support or death)? Yes, No, or Unknown If yes, please select all of the components that apply: Pump Pump Body (including bearings and rotor) Driveline Inflow Cannula Outflow (including bend relief) Controller / Driver Primary System Failure (running in backup mode) Complete System Failure (primary and backup failure) Power Cable (attached to controller) Power Connectors (attached to controller) Peripherals External Battery Cell Battery (in controller) Module Patient Cable System Monitor / Display Battery Charger Battery Clip Outcomes of Device Adverse Event: Malfunction / Failure and/or Pump Thrombus Patient Outcome: Select all that apply: Death (complete the death form) Serious Injury (see FDA/CDRH definition below) Urgent Transplantation (complete the transplant/explant form) Explant Without Replacement (complete the explant form) Exchange (complete the explant form) Breach of Integrity of Line that Required Repair Surgical Procedure None of the Above Causative or Contributing Factors to the Device Adverse Event: Select all that apply: Patient Accident
PedsQL Child (Young Child 5-7 yrs) PHYSICAL FUNCTIONING (problems with…) It is hard for you to walk: 0 – Not at all 2 – Sometimes 4 – A lot Unknown or Not Documented It is hard for you to run: 0 – Not at all 2 – Sometimes 4 – A lot Unknown or Not Documented It is hard for you to play sports or exercise: 0 – Not at all 2 – Sometimes 4 – A lot Unknown or Not Documented It is hard for you to pick up big things: 0 – Not at all 2 – Sometimes 4 – A lot Unknown or Not Documented It is hard for you to take a bath or shower: 0 – Not at all 2 – Sometimes 4 – A lot Unknown or Not Documented It is hard for you to do chores (like pick up your toys): 0 – Not at all 2 – Sometimes 4 – A lot Unknown or Not Documented Do you have hurts or aches: 0 – Not at all 2 – Sometimes 4 – A lot Unknown or Not Documented Do you ever feel too tired to play: 0 – Not at all 2 – Sometimes 4 – A lot Unknown or Not Documented EMOTIONAL FUNCTIONING (problems with…) Do you feel scared: 0 – Not at all
It is hard for me to do sports or exercise: 0 – Not at all 1 – Almost 2 – Sometimes 3 – Often 4 – A lot Unknown or Not Documented It is hard for me to lift something heavy: 0 – Not at all 1 – Almost Never 2 – Sometimes 3 – Often 4 – A lot Unknown or Not Documented It is hard for me to take a bath or shower by myself: 0 – Not at all 1 – Almost Never 2 – Sometimes 3 – Often 4 – A lot Unknown or Not Documented It is hard for me to do chores around the house: 0 – Not at all 1 – Almost Never 2 – Sometimes 3 – Often 4 – A lot Unknown or Not Documented I hurt or ache: 0 – Not at all 1 – Almost Never 2 – Sometimes 3 – 4 – A lot Unknown or Not Documented I have low energy : 0 – Not at all 1 – Almost 2 – Sometimes 3 – Often 4 – A lot Unknown or Not Documented ABOUT MY FEELINGS (problems with…) I feel afraid or scared: 0 – Not at all 1 – Almost 2 – Sometimes 3 – Often 4 – A lot
4 – A lot Unknown or Not Documented I cannot do things other kids my age can do: 0 – Not at all 1 – Almost Never 2 – Sometimes 3 – Often 4 – A lot Unknown or Not Documented It is hard to keep up when I play with other kids: 0 – Not at all 1 – Almost Never 2 – Sometimes 3 – Often 4 – A lot Unknown or Not Documented SCHOOL (problems with…) Is it hard to pay attention in school: 0 – Not at all 1 – Almost Never 2 – Sometimes 3 – 4 – A lot Unknown or Not Documented I forget things: 0 – Not at all 1 – Almost Never 2 – Sometimes 3 – Often 4 – A lot Unknown or Not Documented I have trouble keeping up with schoolwork: 0 – Not at all 1 – Almost Never 2 – Sometimes 3 – Often 4 – A lot Unknown or Not Documented I miss school because of not feeling well: 0 – Not at all 1 – Almost 2 – Sometimes 3 – Often 4 – A lot Unknown or Not Documented I miss school to go to the doctor or hospital: 0 – Not at all 1 – Almost Never
2 – Sometimes 3 – Often 4 – A lot Unknown or Not Documented PedsQL Child (Teen 13-18 yrs) ABOUT MY HEALTH AND ACTIVITIES (problems with…) It is hard for me to walk more than one block: 0 – Not at all 1 – Almost Never 2 – Sometimes 3 – 4 – A lot Unknown or Not Documented It is hard for me to run: 0 – Not at all 1 – Almost Never 2 – Sometimes 3 – Often 4 – A lot Unknown or Not Documented It is hard for me to do sports or exercise: 0 – Not at all 1 – Almost Never 2 – Sometimes 3 – 4 – A lot Unknown or Not Documented It is hard for me to lift something heavy: 0 – Not at all 1 – Almost Never 2 – Sometimes 3 – 4 – A lot Unknown or Not Documented It is hard for me to take a bath or shower by myself: 0 – Not at all 1 – Almost Never 2 – Sometimes 3 – Often 4 – A lot Unknown or Not Documented It is hard for me to do chores around the 0 – Not at all 1 – Almost Never 2 – Sometimes 3 – Often 4 – A lot Unknown or Not Documented
Unknown or Not Documented HOW I GET ALONG WITH OTHERS (problems with…) I have trouble getting along with other teens: 0 – Not at all 1 – Almost Never 2 – Sometimes 3 – Often 4 – A lot Unknown or Not Documented Other teens do not want to be my friend: 0 – Not at all 1 – Almost 2 – Sometimes 3 – Often 4 – A lot Unknown or Not Documented Other teens tease me: 0 – Not at all 1 – Almost Never 2 – Sometimes 3 – 4 – A lot Unknown or Not Documented I cannot do things other teens my age can do: 0 – Not at all 1 – Almost 2 – Sometimes 3 – 4 – A lot Unknown or Not Documented It is hard to keep up with 0 – Not at all 1 – Almost Never 2 – Sometimes 3 – Often 4 – A lot Unknown or Not Documented ABOUT SCHOOL (problems with…) Is it hard to pay attention in school: 0 – Not at all 1 – Almost 2 – Sometimes 3 – Often 4 – A lot Unknown or Not Documented I forget things: 0 – Not at all
3 – Often 4 – Almost Always Unknown or Not Documented EMOTIONAL FUNCTIONING (problems with…) Feeling afraid or scared: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Feeling sad or blue: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Feeling angry: 0 – Never 1 – Almost 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Trouble sleeping: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Worrying: 0 – Never 1 – Almost 2 – Sometimes 3 – 4 – Almost Always Unknown or Not Documented SOCIAL FUNCTIONING (problems with…) Playing with other children: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Other kids not wanting to play with him or her:
0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Getting teased by other children: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Not able to do things that children his or her age can do: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Keeping up when playing with other children: 0 – Never 1 – Almost Never 2 – Sometimes 3 – 4 – Almost Always Unknown or Not Documented SCHOOL FUNCTIONING (problems with…) Doing the same school activities as peers: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Missing school/daycare because of not feeling well: 0 – 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Missing school/daycare to go to the doctor or hospital: 0 – 1 – Almost 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented
2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Low energy level: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented EMOTIONAL FUNCTIONING (problems with…) Feeling afraid or scared: 0 – 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Feeling sad or blue: 0 – 1 – Almost 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Feeling angry: 0 – Never 1 – Almost 2 – Sometimes 3 – 4 – Almost Always Unknown or Not Documented Trouble sleeping: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Worrying about what will happen to him or her: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented SOCIAL FUNCTIONING (problems with…)
1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Taking a bath or shower by him or herself 0 – Never 1 – Almost Never 2 – Sometimes 3 – 4 – Almost Always Unknown or Not Documented Doing chores around the house: 0 – Never 1 – Almost 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Having or aches: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Low energy 0 – 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented EMOTIONAL FUNCTIONING (problems with…) Feeling afraid or scared: 0 – 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Feeling sad or blue: 0 – 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Feeling angry:
0 – 1 – Almost Never 2 – Sometimes 3 – 4 – Almost Always Unknown or Not Documented Trouble sleeping: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Worrying about what will happen to him or her: 0 – 1 – Almost Never 2 – Sometimes 3 – 4 – Almost Always Unknown or Not Documented SOCIAL FUNCTIONING (problems with…) Getting along with other children: 0 – Never 1 – Almost 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Other children not wanting to be his or her friend: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Getting teased by children: 0 – Never 1 – Almost 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Not able to do things that other children his or her age can do: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented
1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Running: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Participating in sports activity or exercise: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Lifting something heavy: 0 – Never 1 – Almost 2 – Sometimes 3 – 4 – Almost Always Unknown or Not Documented Taking a bath or shower by him or herself 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Doing chores around the house: 0 – 1 – Almost Never 2 – Sometimes 3 – 4 – Almost Always Unknown or Not Documented Having hurts or aches: 0 – Never 1 – Almost 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Low energy level: 0 – Never 1 – Almost Never
Other teens not wanting to be his or her friend: 0 – 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Getting teased by other teens: 0 – 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Not able to do things that other teens his or her age can do: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Keeping up with other teens: 0 – Never 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented SCHOOL FUNCTIONING (problems with…) Paying attention in class: 0 – 1 – Almost Never 2 – Sometimes 3 – Often 4 – Almost Always Unknown or Not Documented Forgetting things: 0 – Never 1 – Almost Never 2 – Sometimes 3 – 4 – Almost Always Unknown or Not Documented Keeping up with school schoolwork: 0 – Never 1 – Almost 2 – Sometimes 3 – Often 4 – Almost Always