MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2013-09-06 for CELSIOR (ORGAN PRESERVATION SOLUTION) SOLUTION FOR ORGAN PRESERVATION UNK manufactured by Genzyme Polyclonals S.a.s..
[21103746]
Septic shock due to enterobacter cloacae [septic shock]. Case description: spontaneous report was received on (b)(6) 2013 from a pharmacist regarding a (b)(6) female patient, initials unk. The pt's medical history was not provided. On an unspecified date (b)(6) 2013, the liver and kidney for transplant were preserved with celsior. It was reported that total 12 bags of celsior were used. On (b)(6) 2013, the pt underwent liver and kidney transplant. On an unspecified date following the transplant, the pt developed the life-threatening event of septic shock due to enterobacter cloacae. The outcome for the event was not provided. Concomitant medications were not provided. The intensity fort the event was assessed as served. The reporting pharmacist did not provide the causal relationship of celsior with the event. Manufacturer's comment: as only limited info has been obtained so far, it is difficult to assess a cause and effect relationship.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2950168-2013-00003 |
| MDR Report Key | 3347004 |
| Report Source | 01,05 |
| Date Received | 2013-09-06 |
| Date of Report | 2013-09-02 |
| Date of Event | 2013-01-01 |
| Date Mfgr Received | 2013-09-02 |
| Date Added to Maude | 2013-09-16 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | BRUNO MENDEZ |
| Manufacturer Street | 675 WEST KENDALL STREET |
| Manufacturer City | CAMBRIDGE MA 02142 |
| Manufacturer Country | US |
| Manufacturer Postal | 02142 |
| Manufacturer Phone | 6177686173 |
| Manufacturer G1 | GENZYME POLYCLONALS S.A.S. |
| Manufacturer Street | 58 AVENUE DEBOURG |
| Manufacturer City | LYON |
| Manufacturer Country | FR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CELSIOR (ORGAN PRESERVATION SOLUTION) SOLUTION FOR ORGAN PRESERVATION |
| Generic Name | ORGAN PRESERVATION SOLUTION |
| Product Code | MSB |
| Date Received | 2013-09-06 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | CE334-01/CE345-01/CE353-01 |
| ID Number | UNK |
| Device Expiration Date | 2014-09-01 |
| 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 FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2013-09-06 |