MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-30 for SPS-1 manufactured by Organ Recovery Systems, Inc.9.
[78829525]
Patient Sequence No: 1, Text Type: N, H10
[78829526]
The patient had a heart transplant (b)(6) 2016. Days later the patient stayed on ecmd for fifteen days. At that point, patient was tested for candida glabrata (torulopsis glabrata); e coli, and gram negative rods in blood then for candida parapsilosis. The patient expired nine days later and after autopsy, was found that the fungus had invaded the blood vessels and organs of the heart, pericardial tissue, lungs and thyroid which contributed to multiorgan failure. The noted cause of death was fungem with multiorgan failure. Months later, we received a notice of a voluntary recall of 2 lots of sps-1-static preservation solution. Although the solution is not used for hearts, it was used on the kidneys recovered from that donor. Looking over the patient's past year of microbiology reports, there was no evidence or history of prior fungal infections.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6681021 |
| MDR Report Key | 6681021 |
| Date Received | 2017-06-30 |
| Date of Report | 2017-05-26 |
| Date of Event | 2016-10-12 |
| Report Date | 2017-05-26 |
| Date Reported to FDA | 2017-05-26 |
| Date Reported to Mfgr | 2017-05-26 |
| Date Added to Maude | 2017-06-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | SET, PERFUSION, KIDNEY, DISPOSABLE |
| Product Code | KDL |
| Date Received | 2017-06-30 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORGAN RECOVERY SYSTEMS, INC.9 |
| Manufacturer Address | 1 PIERCE PL. STE. 475W ITASCA IL 60143 US 60143 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2017-06-30 |