MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-07-11 for CELSIOR manufactured by Genzyme Polyclonals S.a.s..
[4646017]
This unsolicited device case from united states was received on (b)(6) 2014 from a nurse. This case is cross referred to (b)(4) (cluster case). This case involves a patient (demographics not provided) who died after complications from pseudomonas infection whose heart was preserved in celsior organ preservation solution (celsior). No past drugs, medical history, concurrent conditions or concomitant medications were reported. On an unknown date, the patient's heart was preserved in celsior, solution for organ preservation (dose, frequency, route, lot/batch number and expiration date: not provided) for organ preservation whilst undergoing heart transplant. On an unknown date, the patient developed pseudomonas infection. On an unknown date, patient died after complications of pseudomonas infection. It was unknown when the autopsy was performed. No corrective treatment was reported. Outcome: fatal. A pharmaceutical technical complaint (ptc) was initiated with global ptc number: (b)(4) and conclusion was pending for the same. Seriousness criteria: dies after complications from pseudomonas infection: serious (death).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2950168-2014-91123 |
| MDR Report Key | 3947323 |
| Report Source | 05 |
| Date Received | 2014-07-11 |
| Date of Report | 2014-07-08 |
| Date Mfgr Received | 2014-07-08 |
| Date Added to Maude | 2014-07-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL MURPHY |
| Manufacturer Street | 55 CORPORATE DRIVE MAIL STOP: 55D-205A |
| Manufacturer City | BRIDGEWATER NJ 08807 |
| Manufacturer Country | US |
| Manufacturer Postal | 08807 |
| Manufacturer Phone | 9089813633 |
| 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 | 2014-07-11 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | * |
| 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. Death | 2014-07-11 |