MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-08-27 for CELSIOR manufactured by Genzyme Polyclonals S.a.s..
[4716824]
This unsolicited device case from united states was received on (b)(6) 2014 from a pharmacist via food and drug administration (health authority reference number: (b)(4)). This case involves a (b)(6) year old pt who underwent donor heart preservation in celsior organ preservation solution (celsior) (off label use) which was complicated with primary graft failure, allograft dysfunction, low ejection fraction, respiratory atypical pneumonia, significant depression/adjustment disorder, pain and pt died. The pt's medical history was significant for eosinophilic myocarditis, advanced congestive heart failure treated with dobutamine (patient's status upgraded to 1b; felt much better and was able to walk 20-30 minutes daily, though the grocery story, cook, and walk single flights of stairs without fatigue and legs giving out; no orthopnea, pnd, chest discomfort, or palpitations), thrombocytopenia, clostridium difficile colitis and left ventricular apical thrombus. Past drugs included metolazone (zaroxolyn) and ace inhibitor (unspecified) and beta blocking agents for chronic renal insufficiency and hypotension. No concurrent conditions were reported. Concomitant medications included warfarin, factor ii (prothrombin/factor ix complex human (prothrombin complex concentrate), pravastatin sodium (pravastatin), spironolactone, bymex, sulfamethoxazole/trimethoprim (cotrimazole) for fungal prophylaxis, valganciclovir hydrochloride (valcyte), heparin and anti-thymocyte globulin (rabbit) (thymoglobulin) for immunosuppression. On an unknown date in 2013, the donor heart for transplant was preserved in celsior, solution for organ preservation (lot number: cie-354-02 and expiration date: unknown) (off label use). On an unknown date, the patients underwent heart transplant. On an unknown date, heart transplant was complicated by primary graft failure requiring multiple inotropes/pressors, placement of intra-aortic balloon pump (iabp) and av ecmo. The patient was taking warfarin at home; however, patient was not complicated by refractory coagulopathy. On an unknown date, patient was transferred to floor (pod#91) from heart transplant complicated by primary graft non? Function. The patient was ready to discharge to acute rehab facility. The patient received tramadol hydrochloride (tramadol} for pain control as per need. The patient's mental status continued to be totally clear. On an unknown date, patient continued significant weakness due to deconditioning continued with aggressive patient. Also, it was reported that patient was presented with significant depression/adjustment disorder, thus patient was being followed by psychiatry who recommended initiation and upward titration of celexa and lorazepam (ativan) as per need. It was reported that cardiovascular continued with allograft dysfunction with low ejection fraction and last rhc which continued to demonstrate elevated filling pressures with emb showing no evidence of rejection. At this time patient was receiving pravastatin sodium, spironolactone and bymex. It was planned to continue the patient with diuresis as tolerated for blood pressure and renal function. It was reported that the patient would be schedule for repeat emb next week as outpatient. It was stated that repeat echocardiogram (echo) continued to show evidence of mass in left ventricular apex. It was planned to get contrasted echo prior to discharge to fully assess. It was reported that patient would start oral aspirin at a dose of 325 mg daily on discharge. It was reported that there was no plans for further anticoagulation at this time secondary to increased risk of bleeding. The biopsy was scheduled. The patient had no active issues at this time. Based on present renal function, the platelet count continued to be normal at this time. The patient would continue to be observed platelet count closely for recovery. The patient would continue to follow for eosinophil count weekly and would be consider for restarting gleevec for diagnosis of eosinophilic myocarditis if absolute eosinophil count was more than 1000. On an unknown date in 2014, the patient became hypoxic. At that time, he was intubated and further evaluation was pursued with a computer tomography (ct) scan of the chest with contrast which revealed multiple bilateral sub segmental pulmonary emboli. The patient was started on heparin. Apparently, patient was treated for cryptococcus atypical pneumonia, fungal and hospital-acquired pathogens with vancomycin, meropenem, levofloxacin (levaquin), tobramycin and voriconazole. The patient's clinical picture showed no improvement despite broad antibiotic coverage for infection, inotropes, cwh, ventilator support for respiratory failure. The patient's clinical picture continued to decline. On an unknown date in 2014, the patient died (unknown cause of death). It was unknown whether autopsy was performed. Outcome: unknown for all the events. Seriousness assessment: respiratory failure and primary graft failure: intervention required and allograft dysfunction, mass in left ventricular apex, low ejection fraction, cyptococcus atypical pneumonia (important medical event).
Patient Sequence No: 1, Text Type: D, B5
[12195423]
A pharmaceutical technical complaint (ptc} was initiated and conclusion was pending for same. Pharmacovigilance comment: sanofi company comment dated (b)(4) 2014: in this case, the causal role of the celsior organ preservation solution cannot be excluded for the occurrence of the events of death nos, graft failure, acute allograft rejection, low ejection fraction, respiratory failure and mass in left ventricular apex, however, the lack of information regarding the autopsy findings of the patient and the further information lack regarding the autopsy details precludes the complete case assessment.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2950168-2014-14767 |
| MDR Report Key | 4100966 |
| Report Source | 05 |
| Date Received | 2014-08-27 |
| Date of Report | 2014-08-19 |
| Date of Event | 2014-01-01 |
| Date Mfgr Received | 2014-08-19 |
| Date Added to Maude | 2014-09-22 |
| 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 DRIVE MS: 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 | 2014-08-27 |
| Lot Number | CIE-354-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Other; 3. Required No Informationntervention | 2014-08-27 |