MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-03-10 for CELSIOR manufactured by Genzyme Polyclonals S.a.s..
[21654296]
This unsolicited device case of united states was received on (b)(4) 2014 from a health care professional (other). This is a summary case of 10 patients who developed some failed heart transplants/graft failure- after undergoing heart transplantations which were preserved with celsior. The medical history, past drugs, concurrent conditions and concomitant medications were not provided for the patients. On unknown dates, the hearts for transplant were preserved in celsior, solution for organ preservation. On unknown dates, the patients underwent heart transplant. It was reported that these patients on unspecified dates, after unknown time frame, had graft failure/failed heart transplant. Treatment: not reported. Outcome: unk. A pharmaceutical technical complaint (ptc) was initiated with global ptc number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[22004482]
Neither the batch number nor the hospital name was reported in the complaints. Regarding batches released and distributed to u. S. Not expired at the date of the complaints, focus of investigation was on five batches: ce307-01, ce325-01, ce354-02, ce370-02 and ce375-01. After investigation and review of manufacturing batch record and the analytical results, no inherent process or testing reason was identified that would impact the quality of the product. The batches comply with their approved specifications and were within the usual trends. For these batches, distributed in u. S. And in many other countries (standard export for ce307 and ce325 and latam for ce354 and ce370), no other complaint has been received to date for the same reason. After investigation, no anomaly in the manufacturing or testing of lots ce307, ce325, ce354, ce370 and ce375 and no issues were found which could have contributed to this complaint issue. Seriousness: important medical event. Additional follow up was received on (b)(4) 2014. No new safety information was received. Therefore, the case was processed as nni (no new information). Additional information was received on (b)(4) 2014. Ptc investigation results were added.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2950168-2014-24227 |
| MDR Report Key | 3687468 |
| Report Source | 05 |
| Date Received | 2014-03-10 |
| Date of Report | 2014-02-24 |
| Date Mfgr Received | 2014-02-24 |
| Date Added to Maude | 2014-03-20 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 55 CORP. DR. MAIL STOP: 55D-205A |
| Manufacturer City | BRIDGEWATER NJ 08807 |
| Manufacturer Country | US |
| Manufacturer Postal | 08807 |
| Manufacturer Phone | 9089816698 |
| 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 | 2014-03-10 |
| Lot 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-03-10 |