MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-11 for SPS PRESERVATION SOLUTION manufactured by Organ Recovery Systems.
[64917363]
I'm not sure if this has been reported, in discussion last night i was informed by my team that in an organ procurement performed this weekend (b)(6) that the preservation solution was foul smelling when the bags were opened, cultures of the preservation solution were obtained and have grown gram negative rods per our opo lifegift the lot numbers for the sps solution are pbr-0060-386 and pbr-0074-332 our pt (liver transplant) is doing well currently and the organ was "washed" with antibiotic containing before repackaging and transplant. This event obviously is similar to the events of (b)(6) involving a recall of this solution are quite concerning regarding the safety of the solution. Please call if you have questions. (b)(6). Therapy start date: (b)(6) 2017. Therapy end date: (b)(6) 2017. Diagnosis or reason for use: preservation solution for organ transplant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067191 |
| MDR Report Key | 6249038 |
| Date Received | 2017-01-11 |
| Date of Report | 2017-01-11 |
| Date of Event | 2017-01-08 |
| Date Added to Maude | 2017-01-13 |
| 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 |
| 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 PRESERVATION SOLUTION |
| Generic Name | SPS PRESERVATION SOLUTION |
| Product Code | KDN |
| Date Received | 2017-01-11 |
| Lot Number | PBR-0060-386, P |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORGAN RECOVERY SYSTEMS |
| Brand Name | SPS PRESERVATION SOLUTION |
| Generic Name | SPS PRESERVATION SOLUTION |
| Product Code | KDN |
| Date Received | 2017-01-11 |
| Lot Number | PBR-0074-332 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | ORGAN RECOVERY SYSTEMS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-11 |