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 2020-03-30 for IMPELLA 2.5 PUMP IMPELLA 2.5 PUMP SET, JAPAN 005048-JP manufactured by Abiomed, Inc..
[185667450]
The root cause was unable to be determined because the product was not returned for review. Data logs do not pertain to the reported failure mode. Dhr was reviewed and found no manufacturing related issues with this lot. There are no other complaints related this failure mode in this lot.
Patient Sequence No: 1, Text Type: N, H10
[185667451]
The complainant reported a (b)(6) japanese male patient had impella 2. 5 pump inserted in the right axillary for acute myocardial infarction and cardiogenic shock (ami/cgs). It was reported the patient experienced a hemorrhage at the implella access site, as a result the impella device was removed. No other treatment was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2020-00397 |
| MDR Report Key | 9897907 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2019-01-10 |
| Date Facility Aware | 2019-06-25 |
| Date Mfgr Received | 2019-06-25 |
| Device Manufacturer Date | 2018-11-21 |
| Date Added to Maude | 2020-03-30 |
| 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 DR |
| Manufacturer City | DANVERS MA 01923 |
| Manufacturer Country | US |
| Manufacturer Postal | 01923 |
| 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 2.5 PUMP |
| Generic Name | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP |
| Product Code | OZD |
| Date Received | 2020-03-30 |
| Model Number | IMPELLA 2.5 PUMP SET, JAPAN |
| Catalog Number | 005048-JP |
| Lot Number | 1375181 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABIOMED, INC. |
| Manufacturer Address | 22 CHERRY HILL DR. DANVERS MA 01923 US 01923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-30 |