MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-05 for IMPELLA CP manufactured by Abiomed.
[111047122]
Impella alarmed with screen showing "impella stopped / retrograde flow" p-level dropped to 0. No kinks or disconnects noted. Despite changing white cables and contacting impella rep for guidance, pt deteriorated and expired despite all resuscitative efforts. Critically ill pt in icu on impella support. On (b)(6) 2018, impella alarms sounded and screen showed "impella stopped, retrograde flow. " impella initially at p-level 6 but dropped to p-level 0 with impella flow + 0. 00l/min. Attempts were made to dial up the p-level back to 6 but device continued to drop to 0. Device assessed for disconnects and kinks. Impella rep contacted, white cables changed. Pt became hemodynamically unstable, cpr initiated. Pt expired despite all resuscitative efforts. Device was immediately turned over to the mfr's rep for investigation. Recently received report from a biomed dated (b)(6) 2018 indicating that a coil short in the impella catheter was likely the source of the product malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7600521 |
| MDR Report Key | 7600521 |
| Date Received | 2018-06-05 |
| Date of Report | 2018-06-01 |
| Date of Event | 2018-02-10 |
| Date Facility Aware | 2018-02-10 |
| Report Date | 2018-06-01 |
| Date Reported to FDA | 2018-06-01 |
| Date Reported to Mfgr | 2018-02-10 |
| Date Added to Maude | 2018-06-14 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | 2018-06-05 |
| Returned To Mfg | 2018-02-10 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABIOMED |
| Manufacturer Address | DANVERS MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-06-05 |