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 2020-03-20 for IMPELLA CP OPTICAL PUMP IMPELLA CP PUMP 371 SET, US 0048-0024 manufactured by Abiomed, Inc..
[184417005]
The impella cp optical was returned by the customer and a failure analysis investigation is underway. A supplemental mdr will be filed at the completion of the device's investigation.
Patient Sequence No: 1, Text Type: N, H10
[184417006]
The complainant reported a (b)(6) white male patient had impella cp optical pump inserted in the right femoral for post cardiac-cardiogenic shock (pccs). Hemolysis was first noticed 20-30 minutes after impella placed and continued to get worse until impella was removed. Hemolysis began to resolve shortly after impella removal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2020-00388 |
| MDR Report Key | 9863037 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-02-24 |
| Date Facility Aware | 2020-02-24 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2019-09-17 |
| Date Added to Maude | 2020-03-20 |
| 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 OPTICAL PUMP |
| Generic Name | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP, |
| Product Code | OZD |
| Date Received | 2020-03-20 |
| Returned To Mfg | 2020-03-02 |
| Model Number | IMPELLA CP PUMP 371 SET, US |
| Catalog Number | 0048-0024 |
| Lot Number | 1433793 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-20 |