MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-29 for SPS-1 manufactured by Organ Recovery Systems, Inc.
[63535328]
Patient Sequence No: 1, Text Type: N, H10
[63535329]
The organ procurement organization forwarded the notice regarding microbial growth being reported in two lots of organ preservation and storage solution. Review of their records showed that this facility transplanted a cadaver left kidney flushed or stored using solution from identified lot numbers. The above information was shared with the surgeons. The kidney recipient has not had any complications or post-transplant adverse events. Recipient has had a biopsy, and it was fine. An appointment was scheduled for the patient to see the transplant physician so that the physician could disclose the information from this notice to the recipient. The ors (organ recovery systems) has cultured the fluid. Culture results are not back but will be posted on their website once received. (b)(6). Two lot numbers of the organ preservation fluid were involved in this case. Pbr-0074-330, expiration 07/01/2018 pbr-0060-392, expiration 06/01/2018. The procurement team and the transplant team did not notice a foul odor to the organ/organ preservation fluid at the time of procurement or transplant. A routine kidney biopsy was taken after the organ was transplanted. No abnormal results. The patient has not shown any signs of infection since receiving the transplant. The patient's discharge status was listed as good/stable when the patient left the transplant facility. There have been no changes to the patient's plan of care as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6212830 |
| MDR Report Key | 6212830 |
| Date Received | 2016-12-29 |
| Date of Report | 2016-12-27 |
| Date of Event | 2016-12-16 |
| Report Date | 2016-12-21 |
| Date Reported to FDA | 2016-12-21 |
| Date Reported to Mfgr | 2016-12-21 |
| Date Added to Maude | 2016-12-29 |
| 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 | ORGAN PRESERVATION FLUID |
| Product Code | KDN |
| Date Received | 2016-12-29 |
| Lot Number | PBR-0074-330 |
| Device Expiration Date | 2018-07-01 |
| 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 | 2016-12-29 |