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..
[66059724]
Patient Sequence No: 1, Text Type: N, H10
[66059725]
Transplant administration received an email from an organ procurement organization (opo) on. 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. Our recipient received a liver and kidney perfused in this solution (lot number pbr-0060-392). The operating room was notified and conducted two separate searches of their inventory, only one bag was found and was removed from the inventory. The pharmacy reported that staff checked the store rooms and did not find any preservation solutions in the two lots cited. The liver service infectious disease physician consulted on the patient and reported that the patient showed no signs or symptom of this infection, patient is stable, afebrile and is 72 days post-transplant currently being treated for a uti. The id consult also stated that the patient has received adequate antibiotic prophylaxis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6285496 |
| MDR Report Key | 6285496 |
| Date Received | 2017-01-30 |
| Date of Report | 2017-01-27 |
| Date of Event | 2016-10-08 |
| 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-0060-392 |
| Device Expiration Date | 2018-06-01 |
| 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 |