MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-30 for SPS-1 manufactured by Organ Recovery Systems Inc.
[66062521]
Patient Sequence No: 1, Text Type: N, H10
[66062522]
Transplant administration received an email from our 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-0060-386. 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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6285499 |
| MDR Report Key | 6285499 |
| Date Received | 2017-01-30 |
| Date of Report | 2017-01-27 |
| Date of Event | 2016-09-18 |
| Report Date | 2017-01-27 |
| Date Reported to FDA | 2017-01-27 |
| Date Reported to Mfgr | 2017-01-27 |
| Date Added to Maude | 2017-01-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPS-1 |
| Generic Name | ORGAN PRESERVATION SOLUTION |
| Product Code | KDL |
| Date Received | 2017-01-30 |
| Lot Number | PBR-0060-386 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORGAN RECOVERY SYSTEMS INC |
| Manufacturer Address | ONE PIERCE PLACE SUITE 475W ITASCA IL 60143 US 60143 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-30 |