MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-03-13 for CELSIOR (ORGAN PRESERVATION SOLUTION) SOLUTION FOR ORGAN PRESERVATION UNK NOT AVAILABLE manufactured by Genzyme Polyclonals S.a.s..
[828801]
Death [death]. Case description: spontaneous report received on 03 march 2008 from a nurse regarding a heart transplant pt (identifiers not provided). The pt received a heart graft that had been preserved with celsior (date of transplant and elapsed time of preservation were not provided). The pt's medical history was not provided. At an unk time after the heart transplant, the pt died (cause and date of death not provided). No further info was provided. Mfr's comment: this is case report 1 of 3 from this reporter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2950168-2008-00001 |
| MDR Report Key | 1012983 |
| Report Source | 05 |
| Date Received | 2008-03-13 |
| Date of Report | 2008-03-03 |
| Date Mfgr Received | 2008-03-03 |
| Date Added to Maude | 2008-03-19 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | WYTSKE KINGMA, MD |
| Manufacturer Street | 675 WEST KENDALL ST. |
| Manufacturer City | CAMBRIDGE MA 02139 |
| Manufacturer Country | US |
| Manufacturer Postal | 02139 |
| Manufacturer Phone | 6177686080 |
| Manufacturer G1 | GENZYME POLYCLONALS S.A.S. |
| Manufacturer Street | 58 AVE. 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 | 2008-03-13 |
| Model Number | UNK |
| Catalog Number | NOT AVAILABLE |
| Lot Number | CE169 |
| ID Number | UNK |
| Device Expiration Date | 2009-10-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 981593 |
| Manufacturer | GENZYME POLYCLONALS S.A.S. |
| Manufacturer Address | LYON FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2008-03-13 |