MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-06 for MEDTRONIC AFFINITY 215858087 manufactured by Medtronic Perfusion Systems.
[126964160]
It was reported there a quality issue with an integrated positive pressure relief valve on my venous reservoir. When initiating cardiopulmonary bypass, the negative venous pressure did not correlate with the vacuum assist regulator pressure. I traced all of my lines and made sure all of my connections were secure. I had other perfusionists come in the room to help me troubleshoot the issue and we found that the integrated positive pressure relief valve was faulty. During closing the surgical site, that positive pressure valve had been sucked into the venous reservoir and was on the back side of the filter screen (still in the reservoir).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081125 |
| MDR Report Key | 8046306 |
| Date Received | 2018-11-06 |
| Date of Report | 2018-11-05 |
| Date of Event | 2018-11-01 |
| Date Added to Maude | 2018-11-07 |
| 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 |
| Reporter Occupation | ATTORNEY |
| 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 | MEDTRONIC AFFINITY |
| Generic Name | RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS |
| Product Code | DTN |
| Date Received | 2018-11-06 |
| Catalog Number | 215858087 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC PERFUSION SYSTEMS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-06 |