MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-14 for BELZER UW COLD STORAGE SOLUTION manufactured by Preservation Solutions Inc..
[100090975]
Patient Sequence No: 1, Text Type: N, H10
[100090976]
Organ recipient was available for a kidney transplant procedure. When the cold storage solution was opened, it was determined to have a "rotten egg" odor. Another bag of the same lot was then opened and the fluid also had the "rotten egg" smell. The kidney was in contact with the cold storage solution. The transplant patient declined this organ and the kidney was not used during the case. Opo was made aware of the event following discussion with hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7269393 |
| MDR Report Key | 7269393 |
| Date Received | 2018-02-14 |
| Date of Report | 2018-02-13 |
| Date of Event | 2018-01-26 |
| Report Date | 2018-02-08 |
| Date Reported to FDA | 2018-02-08 |
| Date Reported to Mfgr | 2018-02-08 |
| Date Added to Maude | 2018-02-14 |
| 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 | BELZER UW COLD STORAGE SOLUTION |
| Generic Name | SYSTEM, PERFUSION, KIDNEY |
| Product Code | KDN |
| Date Received | 2018-02-14 |
| Lot Number | BCD11212117B |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRESERVATION SOLUTIONS INC. |
| Manufacturer Address | 1099 PROCTOR DRIVE ELKHORN WI 53121 US 53121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-14 |