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 2011-12-30 for CELSIOR (ORGAN PRESERVATION SOLUTION) SOLUTION FOR ORGAN PRESERVATION UNK manufactured by Genzyme Polyclonals S.a.s..
[21643511]
After de-clamping, heart didn't restart spontaneously [complications of transplanted heart]. Case description: spontaneous report rec'd from a surgeon on (b)(6) 2011 regarding 5 unspecified heart transplant pts, initials not provided. Celsior administration was not provided. Pt history was not reported. The surgeon reported that in 5 pts the transplanted heart did not restart spontaneously after de-clamping. In 2 of the pts the heart restarted after drug administration, 1 restarted after extracorporeal membrane oxygenation (ecmo), 1 pt died, and the last pt 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. This case refers to the pt that died after the event. The complete list of cases created from this report include (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[21857010]
Mfr's comment: no further details were rec'd. Further info has been requested.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2950168-2011-00001 |
| MDR Report Key | 2401092 |
| Report Source | 00,01,05 |
| Date Received | 2011-12-30 |
| Date of Report | 2011-12-21 |
| Date Mfgr Received | 2011-12-21 |
| Date Added to Maude | 2012-01-09 |
| 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 STREET |
| Manufacturer City | CAMBRIDGE MA 02142 |
| Manufacturer Country | US |
| Manufacturer Postal | 02142 |
| Manufacturer Phone | 6177689000 |
| Manufacturer G1 | GENZYME POLYCLONALS 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 | 2011-12-30 |
| 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 POLYCLONALS S.A.S. |
| Manufacturer Address | LYON FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2011-12-30 |