MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-26 for IMPELLA CP IMPELLA CP PUMP SET, JAPAN 0048-0034-JP manufactured by Abiomed Inc..
[185477259]
The medical team in (b)(6) has discarded the impella pump in (b)(6) of 2019 when the patient expired. Clinical details and the pump data logs are being analyzed. Upon completion of the investigation, a final report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[185477260]
A patient was admitted to the medical facility in (b)(6) after having an acute myocardial infarction at an outlying community hospital. The patient was supported by pcps/ecmo and an intraaortic balloon pump (iabp). Upon admission to the tertiary center the iabp was removed and an impella cp placed for escalated cardiac support. The patient's condition and prognosis were not good, as he had poor liver function and developed multiorgan failure. After 23 days of impella support the patient expired after the family made a decision to not extend measures, and he became a dnr. Months later the medical facility informed the abiomed (b)(6) representatives of a hemorrhage that occurred during the impella support. The team had given the patient extensive blood product infusions. The (b)(6) medical team noted units of 261 erythrocytes, 46 ffp, 160 of platelets, and 55 units of blood.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2020-00393 |
| MDR Report Key | 9887025 |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-02 |
| Date Facility Aware | 2020-03-02 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-10-25 |
| Date Added to Maude | 2020-03-26 |
| 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 CP |
| Generic Name | TEMPORARY NONROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP |
| Product Code | OZD |
| Date Received | 2020-03-26 |
| Model Number | IMPELLA CP PUMP SET, JAPAN |
| Catalog Number | 0048-0034-JP |
| Lot Number | 1441282 |
| 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 DRIVE DANVERS MA 01923 US 01923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-26 |