MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-23 for SPS-1 manufactured by Organ Recovery Systems.
[63490503]
Liveon ny obtained 125 units of organ recovery systems sps-1 with lot numbers that were part of a voluntary removal (pbr-0060-392 received on (b)(6) 2016, pbr-0074-330 received on (b)(6) 2016). In an abundance of caution. Liveon notified every transplant center and tissue bank receiving organs and tissues from any organ donor during that time. (b)(6) transplanted the heart from the donor in this report. Upon notification about the sps-1, they notified liveon ny and unos that their heart recipient had a positive wound culture for candida albicans. While this is not the same organism found in the solution cultures, the final confirmatory cultures have not been reported at this time. This report is based on the possibility of use of one of the effected lot numbers, but use of that lot number cannot be confirmed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5066922 |
| MDR Report Key | 6208988 |
| Date Received | 2016-12-23 |
| Date of Report | 2016-12-23 |
| Date of Event | 2016-12-01 |
| Date Added to Maude | 2016-12-28 |
| 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 | ORGAN PRESERVATION SOLUTION |
| Product Code | KDL |
| Date Received | 2016-12-23 |
| Lot Number | PBR-0060-392 |
| Device Expiration Date | 2018-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORGAN RECOVERY SYSTEMS |
| Manufacturer Address | ITASCA IL 60143 US 60143 |
| Brand Name | SPS-1 |
| Generic Name | ORGAN PRESERVATION SOLUTION |
| Product Code | KDL |
| Date Received | 2016-12-23 |
| Lot Number | PBR-0074-330 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | ORGAN RECOVERY SYSTEMS |
| Manufacturer Address | ITASCA IL 60143 US 60143 |
| Brand Name | SPS-1 |
| Generic Name | ORGAN PRESERVATION SOLUTION |
| Product Code | KDL |
| Date Received | 2016-12-23 |
| Lot Number | PBR-0060-397 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | ORGAN RECOVERY SYSTEMS |
| Manufacturer Address | ITASCA IL 60143 US 60143 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-12-23 |