N
Patient 1
MAUDE MDR 6285498
- MDR report key
- 6285498
- Report number
- 6285498
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-08-16
- Date received
- 2017-01-30
- Adverse event
- 0
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Report source
- U
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SPS-1 | ORGAN PRESERVATION SOLUTION | ORGAN RECOVERY SYSTEMS, INC. | KDL | PBR-0060-386 | * | * |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-01-30 | 0 |
Event Narratives#
D
Patient 1
TRANSPLANT ADMINISTRATION RECEIVED AN EMAIL FROM THE ORGAN PROCUREMENT AGENCY THAT OUR RECIPIENT RECEIVED A LIVER GRAFT THAT WAS PERFUSED WITH A RECALLED BATCH OF ORGAN PRESERVATION SOLUTION. WE WERE MADE AWARE OF A VOLUNTARY RECALL ON CERTAIN BATCHES OF ORGAN PRESERVATION SOLUTION CALLED STATIC PRESERVATION SOLUTION -1 (SPS-1), MANUFACTURED BY ORGAN RECOVERY SYSTEMS. THE RECALL WAS DUE TO A REPORT BY ANOTHER OPO REGARDING BACTERIAL CONTAMINATION. ACCORDING TO THE REPORT THE SOLUTION SAMPLES OBTAINED FROM SEVERAL OPENED BAGS WERE POSITIVE FOR PANTOEA AGGLOMERANS AND ENTEROCOCCUS CASSELIFLAVUS. THIS MICROBIAL GROWTH WAS REPORTED FOR TWO LOTS OF THE PRESERVATION SOLUTION SPS-1.LOTS: PBR-0074-337, EXPIRATION 06/01/2018. OUR PHARMACY WAS MADE AWARE OF THE RECALL SHORTLY AFTER WE RECEIVED NOTICE FROM THE FIRST OPO OVER THE WEEKEND. PHARMACY AND THE OPERATING ROOM IMMEDIATELY QUARANTINED ANY UNUSED INVENTORY FROM THE AFFECTED LOTS. THE PATIENT IS AT HOME AND IS AFEBRILE. AT THE RECOMMENDATION OF OUR ID TEAM WE WILL BE OBTAINING ONE SET OF BLOOD CULTURES ON THIS RECIPIENT AT THEIR NEXT BLOOD DRAW.