MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-17 for AFFINITY manufactured by Medtronic Perfusion Systems.
[97544448]
Patient Sequence No: 1, Text Type: N, H10
[97544449]
Commenced bypass procedure. Blood color was dark indicating blood was not being oxygenated. Surgeon and anesthesia notified immediately. Blood sample was pulled from circuit before coming off of bypass. Came off bypass so patient could breath on his own. Arterial po2 on blood gas from the circuit was 31. Patient's saturation became greater upon breathing on his own. Confirmed oxygen source unobstructed. Confirmed oxygen source was blowing. Moved gas lines to another room to confirm oxygen source. Commenced bypass a second time for 60 seconds. Confirmed oxygenator not working changed out oxygenator. Commenced bypass a third time, and oxygenation was appropriate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7198983 |
| MDR Report Key | 7198983 |
| Date Received | 2018-01-17 |
| Date of Report | 2018-01-10 |
| Date of Event | 2017-12-14 |
| Report Date | 2018-01-10 |
| Date Reported to FDA | 2018-01-10 |
| Date Reported to Mfgr | 2018-01-10 |
| Date Added to Maude | 2018-01-17 |
| 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 | 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 | AFFINITY |
| Generic Name | FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE |
| Product Code | DTM |
| Date Received | 2018-01-17 |
| Model Number | AFFINITY |
| Device Expiration Date | 2019-02-28 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC PERFUSION SYSTEMS |
| Manufacturer Address | 7611 NORTHLAND DR. MINNEAPOLIS MN 55428 US 55428 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-17 |