MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-01-27 for CELSIOR (ORGAN PRESERVATION SOLUTION) SOLUTION FOR ORGAN PRESERVATION UNK manufactured by Genzyme Polyclonals S.a.s..
[2418482]
Acute graft failure [graft dysfunction]. Case description: spontaneous report was received on (b)(6) 2012 from a health professional regarding an organ transplant pt, initials not reported. The pt's medical history was not provided. On an unspecified date, the pt initiated celsior solution for unspecified organ preservation, dose regimen not provided. On an unk date, time after celsior not reported, 2 pts had acute graft failure after this lot of celsior was used. This lot was used in a total of 3 pts. The outcome for the event of acute graft failure was unknown. Concomitant medications were not provided. The intensity and causal relationship of the event to celsior were not provided. This is 1 of 2 cases created for this reported info. Please refer to cels-1000024 for the other case.
Patient Sequence No: 1, Text Type: D, B5
[9594579]
No further details were received. Further info has been requested.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2950168-2012-00008 |
| MDR Report Key | 2434732 |
| Report Source | 05 |
| Date Received | 2012-01-27 |
| Date of Report | 2012-01-23 |
| Date Mfgr Received | 2012-01-23 |
| Date Added to Maude | 2012-02-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2012-01-27 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | CE-262-02 |
| 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 POLYCLONALS S.A.S. |
| Manufacturer Address | LYON FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-01-27 |