MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-31 for SPS-1 manufactured by Organ Preservation Systems.
[66329054]
Recipient received organ that had been preserved in sps-1 preservation fluid, distributed by (b)(4). Recipient later was re-admitted with sepsis, hypotension, and expired. Strength: unk. Route: other, preservation fluid. Therapy date: (b)(6) 2016. Diagnosis or reason for use: organ preservation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067558 |
| MDR Report Key | 6292707 |
| Date Received | 2017-01-31 |
| Date of Report | 2017-01-30 |
| Date of Event | 2017-01-15 |
| Date Added to Maude | 2017-02-01 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | KDN |
| Date Received | 2017-01-31 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORGAN PRESERVATION SYSTEMS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2017-01-31 |