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 2020-03-05 for IMPELLA 2.5 PUMP IMPELLA 2.5 PUMP SET, JAPAN 005048-JP manufactured by Abiomed, Inc..
[182569976]
The impella 2. 5 was discarded by the customer and therefore, investigation of device was not possible. Should any new information be returned, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[182569977]
The complainant reported a (b)(6) japanese male patient had impella 2. 5 pump inserted in the right femoral for acute myocardial infarction and cardiogenic shock (ami/cgs). It was reported that patient developed hemolysis during impella support which was confirmed via pfhg measurements. Impella was re-positioned and p-level's were adjusted. The patient also received 20 units of red blood cell fluid, 480ml of fresh frozen plasma and 500ml albuminar. It was also reported the patient developed sepsis. Per the physician, heart failure after acute myocardial infarction combined with sepsis resulted in long-term impella placement and difficult removal. The patient was upgraded to impella 5. 0 for infection and long-term rehabilitation management.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2020-00369 |
| MDR Report Key | 9795412 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-05 |
| Date of Report | 2020-03-05 |
| Date of Event | 2019-09-26 |
| Date Facility Aware | 2020-02-06 |
| Date Mfgr Received | 2020-02-06 |
| Device Manufacturer Date | 2019-08-15 |
| Date Added to Maude | 2020-03-05 |
| 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 | 2020-03-05 |
| Model Number | IMPELLA 2.5 PUMP SET, JAPAN |
| Catalog Number | 005048-JP |
| Lot Number | 1428735 |
| 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 DR DANVERS MA 01923 US 01923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-05 |