MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-01 for MEDISYSTEMS manufactured by Medisystems.
[59185427]
Upon starting a hemodialysis session on (b)(6) 2016 the hemodialysis tech at the medical center noticed a brownish red particles coming out of the machines arterial transducer port. The pt's blood was returned and a back-up hemodialysis machine was used without the need to recannulate the pt's hemodialysis site. The arterial monitor line and pressure osculating device (pod), which connects to the arterial transducer port prevent blood from backing up to the pt. The pt was not exposed to any contamination. The machine in question was pulled out of service and bloodline was saved. Biomed was notified and further investigation of the machine in questioned revealed what appears to be blood in the interior transducer filter. The blood line vendor (medisystem) was notified. The machine vendor fresenius was also contacted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5065767 |
| MDR Report Key | 6075234 |
| Date Received | 2016-11-01 |
| Date of Report | 2016-11-01 |
| Date of Event | 2016-10-27 |
| Date Added to Maude | 2016-11-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | 0 |
| Brand Name | MEDISYSTEMS |
| Generic Name | STREAMLINE AIRLESS SYSTEM SET |
| Product Code | FKJ |
| Date Received | 2016-11-01 |
| Returned To Mfg | 2016-10-28 |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDISYSTEMS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-11-01 |