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, Inc.
[63201826]
Patient Sequence No: 1, Text Type: N, H10
[63201827]
Approximately 6 days ago, our opo (organ procurement organization) received communication from (b)(6) that there was contaminated organ preservation fluid used in transplant cases. Our opo escalated information regarding patients at our facility. Impacted patients were as follows: we received a notification over the weekend that there was contaminated organ preservation solution discovered per the message from the (b)(6). We received the e-mail from our opo (organ procurement organization) informing us that they checked the solution batch numbers and discovered that we used this solution on several of our patients. A total of six patients at this facility received organ transplants that were affected by the contaminated organ preservation fluid. The first patient was readmitted approximately two weeks after transplant for treatment of hydronephrosis and chronic utis. The second patient received additional medication to cover the potential infection related to the contaminated organ preservation fluid. The third patient's medications during hospitalization and at discharge were adjusted to cover the organisms reported in the contaminated organ preservation fluid. The fourth patient has no signs of infection and had no changes to their plan of care. The fifth patient is being seen by id (infectious disease) consult team and pt on empiric therapy for the organisms in the preservation solution and possible hcap (health care associated pneumonia).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6202031 |
| MDR Report Key | 6202031 |
| Date Received | 2016-12-23 |
| Date of Report | 2016-12-22 |
| Date of Event | 2016-12-16 |
| Report Date | 2016-12-22 |
| Date Reported to FDA | 2016-12-22 |
| Date Reported to Mfgr | 2016-12-22 |
| Date Added to Maude | 2016-12-23 |
| 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 | SYSTEM, PERFUSION, KIDNEY |
| Product Code | KDN |
| Date Received | 2016-12-23 |
| Lot Number | PBR-0074-330 |
| 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 | 1. Other | 2016-12-23 |