CELSIOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-07-14 for CELSIOR manufactured by Genzyme Polyclonals S.a.s..

Event Text Entries

[22142404] This unsolicited device case from united states was received on (b)(4) 2014 from a healthcare professional (nurse). This case was cross referenced to (b)(4) (cluster). This case involves 02 patients (demographics not provided) who died after undergoing heart transplants which were preserved with celsior organ preservation solution (celsior). No past drugs, medical history, concurrent conditions or concomitant medications were reported. On unknown dates, the hearts for transplants were preserved in celsior, solution for organ preservation. On unknown dates, the patients underwent heart transplant. On unknown dates, the patients died (cause of death not provided). It was unknown whether autopsy was performed. No corrective treatment was reported. Outcome: fatal. A pharmaceutical technical complaint (ptc) was initiated and the results were pending for the same. Pharmacovigilance comment: sanofi company follow up comment dated (b)(4) 2014: in this case, the causal role of celsior organ preservation solution cannot be excluded for the occurrence of the event of death nos. However, the lack of information regarding the underlying medical history and the concomitant medications used by the patient precludes the complete case assessment, and moreover the lack of information regarding the autopsy findings of the patient and the further information lack regarding the autopsy details, precludes the complete case assessment.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2950168-2014-91125
• MDR Report Key: 3947259
• Report Source: 05
• Date Received: 2014-07-14
• 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: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: MICHAEL MURPHY
• Manufacturer Street: 55 CORPORATE DR. 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

Device Details

• Brand Name: CELSIOR
• Generic Name: ORGAN PRESERVATION SOLUTION
• Product Code: MSB
• Date Received: 2014-07-14
• Lot Number: UNK
• Operator: OTHER
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: GENZYME POLYCLONALS S.A.S.
• Manufacturer Address: LYONS

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2014-07-14