MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-24 for IMPELLA RP IMPELLA RP EU 0046-0011 manufactured by Abiomed Europe, Gmbh.
[184814385]
The complainant in the eu has not returned product for investigation. The analysis into the clinical report and data logs is on-going at this time. A final report will be submitted upon completion.
Patient Sequence No: 1, Text Type: N, H10
[184814386]
A female patient of (b)(6) was admitted with cardiomyopathy and placed on ecmo. When she was unable to be weaned from the ecmo, the team chose to place bipella support with both an impella cp and impella rp. After 4 days of support there was note of massive hemolysis. The team chose to explant the rp. After the removal the hemolysis began to be rectified over the subsequent 3 days. The team also infuse blood products, in the form of 23 transfusions over 4 days.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2020-00390 |
| MDR Report Key | 9871039 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-03-13 |
| Date Facility Aware | 2020-03-13 |
| Date Mfgr Received | 2020-03-13 |
| Device Manufacturer Date | 2019-09-18 |
| Date Added to Maude | 2020-03-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MR. RALPH BARISANO |
| Manufacturer Street | 22 CHERRY HILL DRIVE |
| Manufacturer City | DANVERS MA 01923 |
| Manufacturer Country | US |
| Manufacturer Postal | 01923 |
| Manufacturer Phone | 9786461400 |
| Manufacturer G1 | ABIOMED EUROPE GMBH |
| Manufacturer Street | NEUENHOFER WEG 3 |
| Manufacturer City | AACHEN 52074 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 52074 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPELLA RP |
| Generic Name | TEMPORARY NONROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP |
| Product Code | PYX |
| Date Received | 2020-03-24 |
| Model Number | IMPELLA RP EU |
| Catalog Number | 0046-0011 |
| Lot Number | 1434427 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABIOMED EUROPE, GMBH |
| Manufacturer Address | NEUENHOFER WEG 3 AACHEN 52074 GM 52074 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-24 |