MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-15 for IMPELLA manufactured by Abiomed, Inc..
[86287562]
Patient Sequence No: 1, Text Type: N, H10
[86287563]
Patient has an impella, and around 0830 the writer was in room checking the device. While i was writing down numbers to transfer into the document flow sheet, the flows dropped to 0 lpm, but the device was still on. I started troubleshooting the connections/device when i noticed it started to smell like burning and some smoke was seen coming from the impella console and the screen had gone black and would not restart. I unplugged the device and replugged it into a new outlet. The charge registered nurse and critical care anesthesia attending were then in the room and attempted to again unplug and replug it back in and restart the console with no success. The smoke had stopped but the smell of burning continued. Once the rep had reached the room the console restarted, but it was continuing to smell like burning so the console was changed out with another one with successful resumption of flow. The patient remained stable throughout and the device was off for about 5 minutes. Perfusion was paged and at bedside. The dr. Was also paged and at bedside - decision made prior to resumption of flow to take the patient to the operating room (or) early for his coronary artery bypass grafting (was already scheduled for the same day at noon). Once flow was re-established the surgical team decided to move forward with going to the operating room and the patient was transported to the operating room at approximately 1000.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6868311 |
| MDR Report Key | 6868311 |
| Date Received | 2017-09-15 |
| Date of Report | 2017-09-07 |
| Date of Event | 2017-09-06 |
| Report Date | 2017-09-07 |
| Date Reported to FDA | 2017-09-07 |
| Date Reported to Mfgr | 2017-09-07 |
| Date Added to Maude | 2017-09-15 |
| 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 | IMPELLA |
| Generic Name | TEMPORARY CARDIAC SUPPORT BLOOD PUMP |
| Product Code | PBL |
| Date Received | 2017-09-15 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABIOMED, INC. |
| Manufacturer Address | 22 CHERRY HILL DRIVE DANVERS MA 01923 US 01923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-15 |