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 2020-03-04 for IMPELLA 2.5 IMPELLA 2.5 PUMP SET, JAPAN 005048-JP manufactured by Abiomed Inc..
[182038170]
No product has been returned, and is not expected to be. The event occurred in (b)(6) of 2019 and abiomed was notified in 2020. Questions have been asked of the team in (b)(6), but knowledge sharing has been hampered by the coronavirus/covid-19 in (b)(6). Upon completion of the investigation, a final report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[182038171]
In (b)(6) a patient was admitted in cardiogenic shock and had an extracorporeal membrane oxygenation (ecmo) and impella 2. 5 placed for hemodynamic support. The impella supported the patient for over 4 days when it was explanted. At the explant date the patient had his angioplasty of the coronary arteries. At explant the patient was noted to be stable and no longer in need of mechanical support. Months after pump explant the medical team informed abiomed of presumed hemolysis during the impella support. The team had treated the hemolysis, presumed to be caused by impella, by infusion of blood products. The japan team infused the japanese infusion of 36 units of blood product. The unit in japan is not equal to that of the usa unit of measure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2020-00366 |
| MDR Report Key | 9787796 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-01-06 |
| Date Facility Aware | 2020-01-06 |
| Date Mfgr Received | 2020-01-06 |
| Device Manufacturer Date | 2019-04-08 |
| Date Added to Maude | 2020-03-04 |
| 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 INC. |
| Manufacturer Street | 22 CHERRY HILL DRIVE |
| Manufacturer City | DANVERS MA 01923 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01923 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPELLA 2.5 |
| Generic Name | TEMPORARY NONROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP |
| Product Code | OZD |
| Date Received | 2020-03-04 |
| Model Number | IMPELLA 2.5 PUMP SET, JAPAN |
| Catalog Number | 005048-JP |
| Lot Number | 1404634 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABIOMED INC. |
| Manufacturer Address | 22 CHERRY HILL DRIVE DANVERS MA 01923 US 01923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-03-04 |