MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-31 for ABIOMED IMPELLA CP PERCUTANIOUS LVAD 0048-0003 manufactured by Abiomed.
[66470832]
Impella cp did not go about 0. 9 l/min or flow after insertion into the patient. Suction alarms also started to show. Impella was repositioned several times without resolution of the problem. Impella pump pulled out and tested in a basin filled with heparinized saline. Suction alarms continued to show during testing. Gross examination of the pump did not reveal any clots caught in the pump cage. New impella catheter was prepped and inserted with no problems encountered. Diagnosis or reason for use: cardiogenic shock.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067613 |
| MDR Report Key | 6297551 |
| Date Received | 2017-01-31 |
| Date of Report | 2017-01-31 |
| Date of Event | 2017-01-24 |
| Date Added to Maude | 2017-02-02 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | ABIOMED IMPELLA CP PERCUTANIOUS LVAD |
| Generic Name | ABIOMED IMPELLA CP PERCUTANIOUS LVAD |
| Product Code | PBL |
| Date Received | 2017-01-31 |
| Model Number | IMPELLA CP |
| Catalog Number | 0048-0003 |
| Device Expiration Date | 2017-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABIOMED |
| Manufacturer Address | DANVERS MA 01923 US 01923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-01-31 |