MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-15 for IMPELLA CP 0048-0003 manufactured by Abiomed, Inc..
[111199309]
Patient Sequence No: 1, Text Type: N, H10
[111199310]
The purge pressure on the impella became elevated (>1000), tubing was checked for kinks, none were found. The impella rep was called and we were advised to change the impella cassette. Impella cassette was changed with no resolution of the alarm. The impella rep was called a second time, and he advised us to turn the p level down to zero for 10 seconds. This was done with the supervision of the attending physician. The purge pressure remained high after this intervention as well. It was attempted to aspirate from the purge line, and still the purge pressure remained elevated. The decision was made to exchange the impella in the cath lab.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7604883 |
| MDR Report Key | 7604883 |
| Date Received | 2018-06-15 |
| Date of Report | 2018-06-11 |
| Date of Event | 2018-06-06 |
| Report Date | 2018-06-11 |
| Date Reported to FDA | 2018-06-11 |
| Date Reported to Mfgr | 2018-06-11 |
| Date Added to Maude | 2018-06-15 |
| 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 | IMPELLA CP |
| Generic Name | IMPELLA CP |
| Product Code | PBL |
| Date Received | 2018-06-15 |
| Model Number | 0048-0003 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DY |
| 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 | 2018-06-15 |