MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-09 for IMPELLA CP 0048-0003 manufactured by Abiomed Inc..
[91915171]
Right fem anterial access was obtained and an impella cp was advanced into the lv. Despite appropriate connections, the impella device was not recognized by the console. The console was restarted and connecting cables exchanged, but the console was still not recognizing the impella. That impella was removed and a second impella cp was rapidly exchanged and successfully placed into the lv. Vf was noted on the monitor and required defibrillation x3 followed by initiation of an amiodarone infusion. Minimal flow was generated by the impella. Decision was made to escalate hemodynamic support to va ecmo. The impella cp was removed from the r-fem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073201 |
| MDR Report Key | 7013607 |
| Date Received | 2017-11-09 |
| Date of Report | 2017-11-06 |
| Date of Event | 2017-10-30 |
| Date Added to Maude | 2017-11-09 |
| 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 |
| 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 | IMPELLA CP |
| Generic Name | TEMPORARY CARDIAC SUPPORT |
| Product Code | PBL |
| Date Received | 2017-11-09 |
| Model Number | 0048-0003 |
| Lot Number | 138963 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABIOMED INC. |
| Manufacturer Address | DANVERS MA 01923 US 01923 |
| Brand Name | IMPELLA CP |
| Generic Name | TEMPORARY CARDIAC SUPPORT |
| Product Code | PBL |
| Date Received | 2017-11-09 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | ABIOMED INC. |
| Manufacturer Address | DANVERS MA 01923 US 01923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-09 |