MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-01-11 for CELSIOR (ORGAN PRESERVATION SOLUTION) SOLUTION FOR ORGAN PRESERVATION UNK manufactured by Genzyme Plyclonals S.a.s..
[19927650]
Acute allograft failure [complications of transplanted hearted]. Case description: spontaneous report was rec'd on (b)(6) 2012 from an other health professional regarding a pt, initials unk, with heart transplant. The pt's medical history was not provided. On an unspecified date, the pt initiated celsior solution for organ preservation, dose regimen not provided. On an unspecified date, the pt experienced acute allograft failure. The action taken with celsior treatment was not provided. The outcome for the event of acute allograft failure was unk. Concomitant medications were not provided. The intensity and causal relationship of the event to celsior were not provided. This is 1 of 2 cases from this rptr regarding acute allograft failure in pts that rec'd this lot of celsior. Please refer to (b)(4) for the second case.
Patient Sequence No: 1, Text Type: D, B5
[20275258]
Mfr's comment: no further details were rec'd. Further info has been requested.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2950168-2012-00005 |
| MDR Report Key | 2426130 |
| Report Source | 05 |
| Date Received | 2012-01-11 |
| Date of Report | 2012-01-06 |
| Date Mfgr Received | 2012-01-06 |
| Date Added to Maude | 2012-01-27 |
| 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 | ORGAN PRESERVATION SOLUTION |
| Product Code | MSB |
| Date Received | 2012-01-11 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | CE262-02 |
| ID Number | UNK |
| Device Expiration Date | 2012-10-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENZYME PLYCLONALS S.A.S. |
| Manufacturer Address | LYONS FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-01-11 |