MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-22 for SPS-1 manufactured by Organ Recovery Systems.
[63133773]
Pt had a renal transplant on (b)(6) 2016. Pt presented to the ed on (b)(6) 2016, from an outside hospital with ct showing retroperitoneal hematoma. Pt underwent surgery to correct an apparent bleed from the iliac artery anastomosis. This resulted in the loss of the transplant allograft. Culture of the iliac artery at the time of surgery grew 4 plus pseudomonas aeruginosa. We were notified by (b)(6) on (b)(6) 2016 that the pt's transplanted organ had been perfused with sps-1 solution lot # pbr-0074-330 expiration 07/01/2018 and/or lot # pbr-0060-392 expiration 06/01/2018. Therapy start date: (b)(6) 2016. Used to preserve or perfuse an organ.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5066871 |
| MDR Report Key | 6199788 |
| Date Received | 2016-12-22 |
| Date of Report | 2016-12-22 |
| Date of Event | 2016-11-17 |
| Date Added to Maude | 2016-12-22 |
| 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 | 3 |
| Brand Name | SPS-1 |
| Generic Name | STATIC PRESERVATION SOLUTION |
| Product Code | KDL |
| Date Received | 2016-12-22 |
| Lot Number | PBR-0074-330 |
| Device Expiration Date | 2018-07-01 |
| 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 | STATIC PRESERVATION SOLUTION |
| Product Code | KDL |
| Date Received | 2016-12-22 |
| Lot Number | PBR-0060-392 |
| Device Expiration Date | 2018-06-01 |
| 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 | 1. Hospitalization; 2. Other | 2016-12-22 |