MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-06-08 for CELSIOR NA manufactured by Cardinal Health.
[661636]
Heart graft ventricular dysfunction. Spontaneous report received on 23 may 2007 from a physician assistant regarding a heart transplant patient (identifiers not provided). The patient received a heart graft that had been preserved with celsior (date of transplant and elapsed time of preservation were not provided) in 2007. The patient's medical history was not provided. During or immediately post, the heart transplant (elapsed time not provided), the patient experienced heart graft ventricular dysfunction. It was the opinion of the physician assistant that the event was possibly related to celsior. No further information was provided. Manufacturer's comment: this is case report 3 of 6 from this reporter; please refer to cels-10025, 10027, 10028, 10029, and 10030 for additional case reports of heart graft ventricular dysfunction.
Patient Sequence No: 1, Text Type: D, B5
[7970146]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2950168-2007-00003 |
| MDR Report Key | 863316 |
| Report Source | 05 |
| Date Received | 2007-06-08 |
| Date of Report | 2007-05-23 |
| Date of Event | 2007-01-01 |
| Date Mfgr Received | 2007-05-23 |
| Date Added to Maude | 2007-06-26 |
| 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 |
| Reporter Occupation | PHYSICIAN ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTINE GRANFIELD |
| Manufacturer Street | 500 KENDALL STREET |
| Manufacturer City | CAMBRIDGE MA 02142 |
| Manufacturer Country | US |
| Manufacturer Postal | 02142 |
| Manufacturer G1 | CARDINAL HEALTH |
| Manufacturer Street | ZI NORD BP 1547 |
| Manufacturer City | LIMOGES CEDEX 9 87021 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 87021 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CELSIOR |
| Generic Name | ORGAN PRESERVATION SOLUTION |
| Product Code | MSB |
| Date Received | 2007-06-08 |
| Catalog Number | NA |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 851066 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | RUE DE DION BOUTON ZI NORD, BP 1547 LIMOGES CEDEX 9 FR 87021 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2007-06-08 |