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.
[63229131]
Patient Sequence No: 1, Text Type: N, H10
[63229132]
Patient received a heart transplant approximately two months ago. Uneventful post transplant course. This patient was affected by the recent safety alert regarding contaminated organ preservation fluid sent out by the united (b)(6). The organ procurement organization (opo) notified this facility that this patient was affected by the safety alert. The patient is doing well and has no changes in the plan of care as a result of the contaminated organ preservation fluid.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6202029 |
| MDR Report Key | 6202029 |
| Date Received | 2016-12-23 |
| Date of Report | 2016-12-22 |
| Date of Event | 2016-12-17 |
| Report Date | 2016-12-22 |
| Date Reported to FDA | 2016-12-22 |
| Date Reported to Mfgr | 2016-12-22 |
| 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 |
| Product Code | KDL |
| Date Received | 2016-12-23 |
| 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 |