MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-24 for SPS-1 manufactured by Organ Recovery Systems.
[65802640]
(b)(6) obtained 125 units of organ recovery systems sps-1 with lot numbers that were part of a voluntary removal (pbr-0060-392 received 08/25/2016, pbr-0074-330 received 10/11/2016). In an abundance of caution, (b)(6) notified every transplant center and tissue bank receiving organs and tissues from any organ donor during that time. The liver/kidney recipient from this donor has been spiking fevers since transplant on (b)(6) 2016. Transplant center reported to opo because of possible use of potentially contaminated sps-1 solution in donor. Therapy start date: (b)(6) 2016. Therapy end date: (b)(6) 2016. Diagnosis or reason for use: routine flush of donor organs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067422 |
| MDR Report Key | 6275635 |
| Date Received | 2017-01-24 |
| Date of Report | 2017-01-20 |
| Date of Event | 2017-01-09 |
| Date Added to Maude | 2017-01-25 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | SPS-1 |
| Generic Name | SPS-1 |
| Product Code | KDL |
| Date Received | 2017-01-24 |
| Lot Number | PBR-0060-392 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORGAN RECOVERY SYSTEMS |
| Brand Name | SPS-1 |
| Generic Name | SPS-1 |
| Product Code | KDL |
| Date Received | 2017-01-24 |
| Lot Number | PBR-0074-330 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | ORGAN RECOVERY SYSTEMS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-24 |