MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-17 for IMPELLA CP PUMP IMPELLA CP PUMP SET, JAPAN 0048-0034-JP manufactured by Abiomed, Inc..
[183927237]
Device discarded by customer. The impella cp pump was discarded by the customer therefore a failure analysis investigation cannot be completed.
Patient Sequence No: 1, Text Type: N, H10
[183927238]
The complainant reported a (b)(6) asian female patient had impella cp pump inserted in the right femoral for preoperative myocardial recovery. The patient received two (2) units of red blood cells (rbcs) for suspected hemolysis. During the case, the patient received a total of 36 units of rbcs, 20 units of fresh frozen plasma (ffp), and 75 grams of albumin for access site bleeding.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2020-00384 |
| MDR Report Key | 9845511 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-30 |
| Date of Event | 2019-09-26 |
| Date Facility Aware | 2020-03-02 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-06-03 |
| Date Added to Maude | 2020-03-17 |
| 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, INC. |
| Manufacturer Street | 22 CHERRY HILL DR |
| 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 PUMP |
| Generic Name | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP, |
| Product Code | OZD |
| Date Received | 2020-03-17 |
| Model Number | IMPELLA CP PUMP SET, JAPAN |
| Catalog Number | 0048-0034-JP |
| Lot Number | 1415058 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-17 |