Age: 13.0
Sex: M
Vaccine: FLUX
Symptoms: Laboratory test normal, Positive airway pressure therapy, Pulmonary arterial hypertension
Clinical narrative: Waste 3 cassettes of RemUnity Remodulin within 6 day period due to; Little bit of blood in the tubing; Remunity remote and Remunity pump alarming occlusion code 8-9128; 1 site bled so much; Subcutaneous site is pretty swollen and site is painful; Subcutaneous site is pretty swollen and site is painful; Initial information received on 29-Nov-2023 regarding an unsolicited valid non-serious courtesy case received from a consumer/non-hcp (non-healthcare professional).  This case involves a 14 years old male patient (85.261 kg) who experienced subcutaneous site is pretty swollen and site is painful, waste 3 cassettes of remunity remodulin within 6 day period due to, 1 site bled so much, little bit of blood in the tubing and remunity remote and remunity pump alarming occlusion code 8-9128 after receiving influenza vaccine and while treated with treprostinil sodium [remodulin].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included selexipag (uptravi); ibuprofen (ibuprofen); sodium chloride (sodium chloride); ketamine hydrochloride (ketamine hydrochloride); glycine max extract (glycine max extract) (Lecithin); levosalbutamol tartrate (levalbuterol tartrate hfa); macrogol 3350 (miralax); fluticasone propionate, salmeterol xinafoate (advair hfa); azelastine hcl (azelastine hcl); clonidine hydrochloride (clonidine hydrochloride); ketoprofen (ketoprofen); peppermint oil [mentha x piperita oil] (peppermint oil [mentha x piperita oil]); bifidobacterium lactis (probiotic [bifidobacterium lactis]); oxygen (oxygen); tadalafil (adcirca); lidocaine hcl (lidocaine hcl); omeprazole (omeprazole); digoxin (digoxin); amitriptyline hcl (amitriptyline hcl); gabapentin (gabapentin); poloxamer (poloxamer); senna alexandrina (ex-lax [senna alexandrina]); calcium pantothenate, cyanocobalamin, folic acid, liver, nicotinamide, pyridoxine hydrochloride, riboflavin, riboflavin, saccharomyces cerevisiae, thiamine mononitrate (b complex [calcium pantothenate;cyanocobalamin;folic acid;liver;nicotinamide;pyridoxine hydrochloride;riboflavin;saccharomyces cerevisiae;thiamine mononitrate]); loratadine (loratadine); and ambrisentan (ambrisentan).  On 14-Jun-2023, the patient started taking Treprostinil Sodium 10 mg/ml Injection 0.059 ug/kg via subcutaneous route (with an unknown dose, frequency, expiry date, batch number) for Pulmonary arterial hypertension.  On an unknown date, the patient received an unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (with an unknown formulation, strength, expiry date, lot number) via unknown route in unknown administration site for influenza immunization.  On 11-Nov-2023, the patient developed event of little bit of blood in the tubing (device infusion issue) (latency: 4 months 28 days) following the first dose intake of Treprostinil Sodium and (latency: unknown) following the administration of influenza vaccine.  On 14-Nov-2023, the patient developed events of waste 3 cassettes of remunity remodulin within 6 day period due to (infusion site reaction) (latency: 5 months) following the first dose intake of Treprostinil Sodium and (latency: unknown) following the administration of influenza vaccine.  On an unknown date in Nov-2023, the patient events of subcutaneous site is pretty swollen and site is painful (infusion site pain) (infusion site swelling), 1 site bled so much (infusion site haemorrhage), remunity remote and remunity pump alarming occlusion code 8-9128 (device failure) (unknown latency).  It was reported, This United States case is a spontaneous report received on 11 Nov 2023, from a consumer's father and consumer's mother via Accredo specialty pharmacy. Additional information was received as spontaneous report on 14 Nov 2023, from consumer's mother via Accredo specialty pharmacy. This 14 year old, 188 lbs, male patient began therapy with Remodulin (treprostinil sodium, concentration 10 mg/ml), delivered via Remunity (patient filled) pump, on 14 Jun 2023 for primary pulmonary arterial hypertension. The current dose was reported as 0.059 Î¼g/kg, (self-fill cassette with 2.7 ml. rate of 30 mcl per hour), continuous via subcutaneous (SQ) route. On 07 Nov 2023, the patient had a Remunity site change and on an unreported date in Nov 2023, patient's Remodulin Remunity subcutaneous site was pretty swollen, and site was painful (infusion site swelling, and infusion site pain). It was also reported that, the Remunity remote and Remunity pump alarming occlusion code 8-9128, (device failure) and when cassette was changed on 11 Nov 2023 a little bit of blood in the tubing (device infusion issue) was noted. The infusion was restarted at 30 mcl/hour. Remunity pump serial number were 0014352 or 0014353 and remote serial number were not provided. Further as per report received on 14 Nov 2023, it was reported that patient had to waste 3 cassettes of Remunity Remodulin within 6-day period due to multiple site issues (infusion site reaction). He had to insert 2 new sites, and 1 site bled so much (infusion site haemorrhage) that it required emergency room care visit. It was also reported that 1 week ago, the patient had received a flu shot on the same arm where 1 site had issue and took ibuprofen too. The physician was unable to find the reason for excessive bleeding. Lab tests were performed and were found to be okay. The patient was placed on CPAP (continuous positive airway pressure).   Action taken: Treprostinil sodium (remodulin) was continued and with influenza vaccine (influenza vaccine) was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events