MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-08-30 for CELSIOR (ORGAN PRESERVATION SOLUTION) SOLUTION FOR ORGAN PRESERVATION UNK manufactured by Genzyme Polyclonals S.a.s..
[3818297]
Left ventricular dysfunction [left ventricular dysfunction]. Heart did not work [complications of transplanted heart]. Case description: spontaneous report was received on (b)(6) 2013 from a physician regarding a male pt (age 50-60), initials unk. The pt's medical history was not provided. On an unspecified date, the heart for transplant was preserved with celsior. Later, the pt underwent heart transplant. The lot number for celsior was not provided. It was reported that the pt had generalised dysfunction of heart and profound left ventricular dysfunction. The company assessed the event of left ventricular dysfunction as medically significant. At the time of report, the pt had not yet recovered from both the events. Concomitant medications were not provided. The intensity for both the events was not provided. The reporting physician did not provide the causal relationship of celsior with both the events.
Patient Sequence No: 1, Text Type: D, B5
[11197717]
As only limited info has been obtained so far, it is difficult to assess a cause and effect relationship.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2950168-2013-00002 |
| MDR Report Key | 3346740 |
| Report Source | 05 |
| Date Received | 2013-08-30 |
| Date of Report | 2013-08-21 |
| Date Mfgr Received | 2013-08-21 |
| Date Added to Maude | 2013-09-13 |
| 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 | BRUNO MENDEZ |
| Manufacturer Street | 675 WEST KENDALL ST |
| Manufacturer City | CAMBRIDGE MA 02142 |
| Manufacturer Country | US |
| Manufacturer Postal | 02142 |
| Manufacturer Phone | 6177686173 |
| 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 | 2013-08-30 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| 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 | 2013-08-30 |