MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-14 for SPS-1 manufactured by Organ Recovery System.
[62802313]
During the organ recovery process on a (b)(6)/f, it was noticed that there was a foul odor coming from the preservation solution used during the recovery process. The lungs had been recovered and were already transplanted when this was discovered. The preservation solution was sent for gram stain and cultures, and initial reports from the gram stain indicated many gram positive cocci, many gram negative rods, moderate gram positive rods. At that time, the transplant of the liver, kidney, and kidney/pancreas was stopped. The lungs were flushed with a different preservation solution and had already been transplanted. The lung team was notified of the gram stain results, and the abdominal organs were discarded. Dose or amount: 1000 ml millilitre(s), 2000 ml millilitre(s), route: intravenous. Therapy dates: (b)(6) 2016, diagnosis or reason for use: organ recovery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5066727 |
| MDR Report Key | 6180858 |
| Date Received | 2016-12-14 |
| Date of Report | 2016-12-13 |
| Date of Event | 2016-12-12 |
| Date Added to Maude | 2016-12-16 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 2016-12-14 |
| Returned To Mfg | 2016-12-13 |
| Lot Number | PBR-0060-392 |
| Device Expiration Date | 2018-06-30 |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORGAN RECOVERY SYSTEM |
| Brand Name | SPS-1 |
| Generic Name | SPS-1 |
| Product Code | KDL |
| Date Received | 2016-12-14 |
| Lot Number | PBR-0074-330 |
| Device Expiration Date | 2018-07-31 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | ORGAN RECOVERY SYSTEM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-14 |