MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-04-29 for CELSIOR manufactured by Genzyme Polyclonals S.a.s..
[4478433]
This unsolicited device case from united states was received on (b)(6) 2014 from a physician. This case concerns five patients of unknown demographics who developed heart graft failures after receiving treatment with celsior organ preservation solution (celsior). No relevant medical histories, past drugs, concurrent conditions or concomitant medications were reported for any of the patients. On unspecified dates, the patients received treatment with celsior organ preservation solution, solution for organ preservation (route of administration, dosage regimen, lot/batch number and expiration date unknown) for organ preservation. It was reported that, cluster of graft failures were observed; 5 out of 8 heart grafts had failed over the period since 2013. Corrective treatment: not reported. Outcome: unknown. Seriousness criteria: important medical event. A pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2950168-2014-53783 |
| MDR Report Key | 3804569 |
| Report Source | 05 |
| Date Received | 2014-04-29 |
| Date of Report | 2014-04-21 |
| Date of Event | 2013-01-01 |
| Date Mfgr Received | 2014-04-21 |
| Date Added to Maude | 2014-05-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL MURPHY |
| Manufacturer Street | 55 CORPORATE DRIVE, 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 | 2014-04-29 |
| Lot Number | UNK |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-04-29 |