MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-23 for SPS-1 manufactured by Organ Recovery Systems, Inc.
[63200774]
Patient Sequence No: 1, Text Type: N, H10
[63200775]
Received kidney from opo (organ procurement organization), implanted in patient. Approximately 43 days after implant, received general notice from (b)(6) regarding the contamination of organ preservation fluid. The following day, received notice from opo that they had used the affected lots. Two days after opo notice, received notice from opo that one of our patient's had received kidney from the affected lot of contaminated organ preservation fluid. Our hospital epidemiologists reviewed patient chart. Determined that patient complications were not due to contaminated fluid.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6202036 |
| MDR Report Key | 6202036 |
| Date Received | 2016-12-23 |
| Date of Report | 2016-12-21 |
| Date of Event | 2016-11-03 |
| Report Date | 2016-12-21 |
| Date Reported to FDA | 2016-12-21 |
| Date Reported to Mfgr | 2016-12-21 |
| Date Added to Maude | 2016-12-23 |
| 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 | SYSTEM, PERFUSION, KIDNEY |
| Product Code | KDN |
| Date Received | 2016-12-23 |
| Lot Number | PBR-0060-392 |
| Device Expiration Date | 2018-06-01 |
| Device Availability | N |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORGAN RECOVERY SYSTEMS, INC |
| Manufacturer Address | 1 PIERCE PL STE 475W ITASCA IL 60143 US 60143 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-23 |