SPS-1
Received Jan 30, 2017 · Event occurred Nov 17, 2016
Report 6285497 · MDR key 6285497
Device
Generic name
Organ Preservation Solution
Manufacturer
Organ Recovery Systems, Inc.Lot number
PBR-0074-330
Product problems
- Microbial Contamination of Device
Patient
5 YR
- Fever
- Fever
Narrative
Description of Event or Problem
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, LOT: PBR-0074-330, EXPIRATION 07/01/2018 LOT: PBR-0060-392, 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. OUR RECIPIENT WAS ADMITTED FOR A FEVER WORKUP.
Description of Event or Problem
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: LOT: PBR-0074-330, EXPIRATION 07/01/2018, LOT: PBR-0060-392, 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. OUR RECIPIENT WAS ADMITTED FOR A FEVER WORKUP.