MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-08-26 for CELSIOR manufactured by Genzyme Polyclonals S.a.s..
[4735616]
This unsolicited device case from united states was received on (b)(6) 2014 from pharmacist. This case involves a (b)(6) male patient who developed primary graft failure, refractory coagulopathy, respiratory insufficiency, acute renal failure, primary graft dysfunction, leucopenia, aspergillus pneumonia, pseudomonas pneumonia, steroid induced icu myopathy and later died after undergoing heart transplant which were preserved with celsior organ preservation solution (celsior) (off label use) medical history included congestive heart failure, hyperlipidemia, gastroesophageal reflux disease and hyperuricemia. No past drugs, concurrent conditions or were reported. Concomitant medications included midodrine as blood pressure support, esomeprazole as gastrointestinal prophylaxis, heparin as deep venous thrombosis prophylaxis, meropenem (merrem) , linezolid (zyvox), valganciclovir and sulfamethoxazole/ trimethoprim (smz/tmp) both as cmv prophylaxis. No past drugs and concurrent conditions were reported. On an unknown date, the heart for transplant was preserved in celsior, solution for organ preservation (batch/lot number: ce-307-01 and expiration date: unknown). On an unknown date in 2013, the patient underwent heart transplant with post-operative course complicated by primary graft failure which required multiple pressors and inotropes, developed refractory coagulopathy, respiratory insufficiency, and placement of intra-aortic balloon pump (iabp), followed by centrimag for continued failure of the right ventricle. On an unknown date in 2013, right ventricular assist device (rvad) was explanted and chest was reported to be closed. It was reported that the post-operative course was also complicated by development of renal failure. The patient received intermittent hemodialysis and continuous veno-venous hemofiltration (cvvh). On an unknown date, the patient also developed intensive care unit (icu) myopathy, which was believed to be steroid-induced. On an unknown date in 2013, trach and polyethylene glycol were placed; percutaneous drain of gall bladder was planned to be kept for 06 weeks and also, polyethylene glycol tube was converted to percutaneous jejunostomy. It was reported that the patient was pod #64 from heart transplantation complicated by primary graft dysfunction, refractory coagulopathy, respiratory insufficiency, steroid induced icu myopathy and acute renal failure requiring cvvh. It was reported that for immunosuppression, tacrolimus dose was increased to 1. 5 mg and dose of mycophenolate mofetil was reduced due to recent leucopenia and invasive aspergillosis. However, steroid dose has been tapered rapidly over hospital course due to neurology's concern for possible steroid-induced myopathy and the dose was reduced based on negative biopsies. The patient received intravenous methylprednisolone 10 mg daily with no plan to further reduce the dose at this time. Later, on an unknown date, pulmonary function had improved over hospital course; placed on trach collar with 40% fio2. The patient had acute renal failure, recently changed from intermittent hemodialysis back cvvh. Since 2013, the patient had consistently grown pseudomonas from respiratory cultures, growing 2 strains of pseudomonas (1st strain susceptible only to aminoglycosides, 2nd strain susceptible to aminoglycosides, cefepime and aztreonam). Patient's pseudomonas was treated with gentamicin sulfate (gentamicin). Also, biopsy of lung nodule and fungal culture were positive for aspergillosis which was treated with voriconazole. Also, cefepime was started instead to double cover pseudomonas. However, cardiac function appeared to be resolved with evidence of preserved heart function. The patient underwent several biopsies which showed grade or rejection and while on immunosuppression, patient developed aspergillus pneumonia, which was treated by voriconazole. The patient had clinical improvement initially, but subsequently developed pseudomonas pneumonia, which was resistant to meropenem. The patient developed clinical decompensation with development of pseudomonas pneumonia and required need of pressors, levophed and vasopressin a. On an unknown date, the patient died of an unknown cause. It was unknown whether autopsy was performed. Action taken with methylprednisolone: dose reduced. Outcome: fatal for the event of death nos; unknown for the events of primary graft failure, refractory coagulopathy, acute renal failure, primary graft dysfunction, leucopenia, aspergillus pneumonia, pseudomonas pneumonia and steroid induced icu myopathy recovering/ resolving for the event of respiratory insufficiency.
Patient Sequence No: 1, Text Type: D, B5
[12009296]
A pharmaceutical technical complaint (ptc) was initiated and results were pending for the same. Seriousness criterion: hospitalization for all events pharmacovigilance comment: sanofi company comment dated (b)(4) 2014: this case concerns a patient who experienced primary graft dysfunction, graft failure, refractory coagulopathy, respiratory insufficiency, acute renal failure, steroid induced icu myopathy, leucopenia, pseudomonas pneumonia and aspergillus pneumonia and died. In this case, the causal role of celsior organ preservation solution cannot be excluded for the occurrence of the events, however, the lack of information regarding the underlying medical history and the concomitant medications used by the patient and moreover the lack of information regarding the autopsy findings of the patient precludes the complete case assessment.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2950168-2014-14766 |
| MDR Report Key | 4046807 |
| Report Source | 05 |
| Date Received | 2014-08-26 |
| Date of Report | 2014-08-19 |
| Date Mfgr Received | 2014-08-19 |
| Date Added to Maude | 2014-08-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL MURPHY |
| Manufacturer Street | 55 CORPORATE DR. MAIL STOP: 55D-205A |
| Manufacturer City | BRIDGEWATER NJ 08807 |
| Manufacturer Country | US |
| Manufacturer Postal | 08807 |
| Manufacturer Phone | 9089813633 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CELSIOR |
| Generic Name | ORGAN PRESERVATION SOLUTION |
| Product Code | MSB |
| Date Received | 2014-08-26 |
| Lot Number | CE-307-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENZYME POLYCLONALS S.A.S. |
| Manufacturer Address | LYON FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization | 2014-08-26 |