MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-08-29 for CELSIOR (ORGAN PRESERVATION SOLUTION) SOLUTION FOR ORGAN PRESERVATION UNK manufactured by Genzyme Polyclonais S.a.s..
[20269118]
Left ventricular dysfunction. Hearts aren't functioning as well after transplant/heart didn't work [complications of transplanted heart]. Case description: spontaneous report was received on (b)(6) 2013, from a non-health professional (additional information was received on (b)(6) 2013, from a physician which upgraded the case to serious) regarding a male patient, age not provided (around 50-60), initials unk. The patient's medical history was not provided. On an unspecified date, the hearts for transplant were preserved with celsior. The lot number of celsior was not provided. Later, the patient underwent heart transplant. It was reported that the patient had generalized dysfunction of heart and profound left ventricular dysfunction (hearts did not work after the transplant) and the patient visited the operation room. The event of left ventricular dysfunction was assessed as medically significant by the company. At the time of report, the patient had not yet recovered from the events of left ventricular dysfunction and generalized dysfunction of heart and (hearts aren't functioning as well after transplant/heart didn't work). Concomitant medications were not provided. The intensity for both the events was not provided. The reporting physician did not provide the causal relationship between celsior and both the events.
Patient Sequence No: 1, Text Type: D, B5
[20492339]
Manufacturer's comment: as only limited information 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 | 2950168-2013-00001 |
| MDR Report Key | 3330920 |
| Report Source | 05 |
| Date Received | 2013-08-29 |
| Date of Report | 2013-08-19 |
| Date Mfgr Received | 2013-08-21 |
| Date Added to Maude | 2013-09-10 |
| 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 STREET |
| Manufacturer City | CAMBRIDGE MA 02142 |
| Manufacturer Country | US |
| Manufacturer Postal | 02142 |
| Manufacturer Phone | 6177686173 |
| Manufacturer G1 | GENZYME POLYCLONAIS 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 | 2013-08-29 |
| 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 POLYCLONAIS S.A.S. |
| Manufacturer Address | LYON FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-08-29 |