MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-08-25 for CELSIOR manufactured by Genzyme Polycionals S. A. S..
[4807928]
Based on information received on (b)(6) 2014, the report previously considered as non-valid became valid number of patients was added. This unsolicited summary device case from united states was received on (b)(6) 2014 from another healthcare professional. The case was cross-referred with cases: (b)(6) (cluster) and (b)(6) (duplicate). This case involves five patients (demographics unspecified) who experienced delayed graft function after undergoing heart transplant 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 transplant were preserved in celsior, solution for organ preservation. On unknown dates, the patients underwent heart transplant on unspecified dates, after unknown time frame, the patients had delayed graft function. Reportedly, they expected to have good outcomes but they did not. No corrective treatment was reported. Outcome: unknown. Seriousness criteria: important medical event.
Patient Sequence No: 1, Text Type: D, B5
[12328358]
A pharmaceutical technical complaint (ptc) was initiated with global ptc number: 31606. After investigation and review of manufacturing batch record and the analytical results, no inherent process or testing reason was identified that could impact the quality of the product. The batches comply with their approved specifications and were within the usual trends. For these batches, distributed in us 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. To be noted that heart graft failure could be due to many reasons: surgery, infections, graft versus host disease. After investigation, no anomaly in the manufacturing or testing of lots ce307, ce325, ce354 and ce375 and no issues were found which could have contributed to those complaints issue. A product return was requested to the complainant. This investigation report will be re-opened if when product will be returned. Global conclusion for batch lot ce370 stated that the batch record is conform and the manufacturing of this batch is not impacted by any deviation or change control that could affect the quality of the solution. The batch complied with their approved specifications and were within the usual trends. After investigation, no anomaly in the manufacturing or testing of lot ce370 and no issues were found which could have contributed to this complaint issue. Additional information was received on (b)(4) 2014. Ptc investigation results were added. Follow up was received on (b)(4) 2014. As there was no new safety information received, this follow up was processed as no new information. Follow up was received on (b)(4) 2014. The related cases were added and the information was processed as non? Significant information. Additional information was received on (b)(4) 2014. Ptc results for batch lot ce370 were added. Additional information was received on (b)(4) 2014. The report previously considered as non-valid became valid because number of patients was added. The event term of "some issues with their heart transplant" was updated to "delayed graft function after undergoing heart transplant". Cross referenced case was added. Clinical course updated and text amended accordingly. Pharmacovigilance comment: sanofi company comment dated (b)(4) 2014: this case concerns five patients who developed delayed graft function after undergoing heart transplantations after using celsior organ preservation solution for organ preservation. Although the role of the organ preservation solution cannot be ruled out based on the device event temporal relationship; however, lack of detailed information about medical history, lab data, any concurrent medical illnesses, clinical course etc. Of the patient precludes a comprehensive assessment in this case. Sanofi company comment (b)(4) 2014: ptc test results were received in the follow up. The medical assessment of the case is not altered. Sanofi company comment (b)(4) 2014: ptc test results were received in the follow up. The medical assessment of the case is not altered. Sanofi company comment dated (b)(4) 2014: this case concerns a group of patients who had some issues with their heart transplants after using celsior organ preservation solution for organ preservation. Although the role of the organ preservation solution cannot be ruled out based on the device event temporal relationship; however, lack of detailed information about medical history, lab data, any concurrent medical illnesses, clinical course etc. Of the patient precludes a comprehensive assessment in this case.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2950168-2014-54576 |
| MDR Report Key | 4060376 |
| Report Source | 05 |
| Date Received | 2014-08-25 |
| Date Mfgr Received | 2014-08-20 |
| Date Added to Maude | 2014-09-05 |
| 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 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 | 2014-08-25 |
| 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 POLYCIONALS S. A. S. |
| Manufacturer Address | LYON |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-08-25 |