MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-22 for ORGAN PRESERVATION SOLUTION SPS manufactured by Organ Recovery Systems.
[63237667]
The pt received a deceased donor lung transplant on (b)(6) 2016. The abdominal organs of the donor were flushed with a particular organ preservation solution that has since been recalled. Details regarding the recall are listed below: mfr: organ recovery systems (ors) product: organ preservation solution sps-1 lot number: pbr-0074-330 expiration 07/01/2018 and pbr-0060-392 expiration 06/01/2018. The recall involved in foul odor coming from a container of solution. Upon further investigation, it was determined that the two lot numbers may n=be contaminated and cultures obtained did grow gram=negative and gram=positive bacteria, including pantoea agglomerans and enterococcus casseliflavus. We do not know if the donor lungs came in contact with the solution. The pt had recovered from the transplant without incident thus far. Our facility, university transplant center ((b)(6)) does not stock this particular brand of solution. ) route: other, therapy start date: (b)(6) 2016. Therapy end date: (b)(6) 2016. Are the products compounded? Yes. Diagnosis or reason for use: organ flush/preservation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5066895 |
| MDR Report Key | 6202788 |
| Date Received | 2016-12-22 |
| Date of Report | 2016-12-22 |
| Date of Event | 2016-10-26 |
| Date Added to Maude | 2016-12-23 |
| 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 | ORGAN PRESERVATION SOLUTION SPS |
| Generic Name | ORGAN PRESERVATION SOLUTION SPS |
| Product Code | KDL |
| Date Received | 2016-12-22 |
| Lot Number | PBR-0074-330 |
| Device Expiration Date | 2018-07-01 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORGAN RECOVERY SYSTEMS |
| Brand Name | ORGAN PRESERVATION SOLUTION SPS-1 |
| Generic Name | ORGAN PRESERVATION SOLUTION SPS-1 |
| Product Code | KDL |
| Date Received | 2016-12-22 |
| Lot Number | PBR-0060-392 |
| Device Expiration Date | 2018-06-01 |
| Device Availability | N |
| 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. Other | 2016-12-22 |