MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05 report with the FDA on 2012-01-03 for CELSIOR (ORGAN PRESERVATION SOLUTION) SOLUTION FOR ORGAN PRESERVATION UNK manufactured by Genzyme Polyclonials S.a.s..
[15579422]
After de-clamping, heart didn't restart spontaneously [complications of transplanted heart]. Case description: spontaneous report received from a surgeon on (b)(6) 2011 regarding 4 unspecified heart transplant patients, initials not provided. Celsior administration information was not provided. Patient history was not reported. The surgeon reported that in 5 patients the transplanted heart did not restart spontaneously after de-clamping. In 2 of the patients the heart restarted after drug administration, 1 restarted after extracorporeal membrane oxygenation (ecmo), 1 patient died, and the last patient was on ecmo at the time of this report. Concomitant medications were not reported. Intensity was not provided. Causal relationship to thymoglobulin was considered possible. This is 1 of 5 reports of heart graft dysfunction from this surgeon. The complete list of cases created from this report include (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[15869340]
No further details were received. Further information has been requested.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2950168-2012-00001 |
| MDR Report Key | 2404297 |
| Report Source | 00,01,05 |
| Date Received | 2012-01-03 |
| Date of Report | 2011-12-21 |
| Date Mfgr Received | 2011-12-21 |
| Date Added to Maude | 2012-01-11 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | JILL ROBINSON R., PH, MBA |
| Manufacturer Street | 675 WEST KENDALL ST. |
| Manufacturer City | CAMBRIDGE MA 02142 |
| Manufacturer Country | US |
| Manufacturer Postal | 02142 |
| Manufacturer Phone | 6177689000 |
| Manufacturer G1 | GENZYME POLYCLONIALS S.A.S. |
| Manufacturer Street | 58 AVENUE DEBOURG |
| Manufacturer City | LYON |
| Manufacturer Country | FR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CELSIOR (ORGAN PRESERVATION SOLUTION) SOLUTION FOR ORGAN PRESERVATION |
| Generic Name | NONE |
| Product Code | MSB |
| Date Received | 2012-01-03 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENZYME POLYCLONIALS S.A.S. |
| Manufacturer Address | LYON FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-01-03 |