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 Polyclonals S.a.s..
[2454857]
No mechanical nor electrical activity of the graft [complications of transplanted heart]. Case description: spontaneous report received from a surgeon on (b)(6) 2011 regarding a (b)(6) female heart transplant patient, initials (b)(6). Celsior was given once for organ preservation on (b)(6) 2011. Patient history was not reported. On (b)(6) 2011, the day of celsior administration, after heart transplantation and at the end of anastomosis there was no mechanical nor electrical activity of the graft. Both biopsy and cross match testing was negative. Concomitant medications reported were atg fresenius (antithymocyte immunoglobulin), solu medrol (methylprednisolone sodiumsuccinate), antra (omeprazole sodium), and augmentin (amoxicillin). It was the opinion of the surgeon that the event was severe in intensity and possibly related to celsior. This is 1 of 5 reports from this surgeon of heart graft dysfunction after transplantation. 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). No further details were received. Further information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2950168-2012-00004 |
| MDR Report Key | 2400664 |
| Report Source | 00,01,05 |
| Date Received | 2012-01-03 |
| Date of Report | 2011-12-21 |
| Date of Event | 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 | 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 POLYCLONALS S.A.S. |
| Manufacturer Address | LYON FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2012-01-03 |