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 2020-03-18 for IMPELLA CP OPTICAL PUMP IMPELLA CP PUMP 371 SET, US 0048-0024 manufactured by Abiomed, Inc..
[183926704]
Device has not been returned. The impella cp optical pump was not returned by the customer therefore a failure analysis investigation cannot be completed. If the device is received after this date, an evaluation will be performed and a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[183926705]
The complainant reported a (b)(6) old white male patient had impella cp optical pump inserted in the left femoral for acute myocardial infarction (ami)/cardiogenic shock (cgs). The patient had limb ischemia despite fem and the pump was explanted. Another pump was inserted in the right axillary.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2020-00385 |
| MDR Report Key | 9848467 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-02-17 |
| Date Facility Aware | 2020-02-17 |
| Date Mfgr Received | 2020-02-17 |
| Device Manufacturer Date | 2020-01-08 |
| Date Added to Maude | 2020-03-18 |
| 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 | 2020-03-18 |
| Model Number | IMPELLA CP PUMP 371 SET, US |
| Catalog Number | 0048-0024 |
| Lot Number | 1454868 |
| 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 DR DANVERS MA 01923 US 01923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-18 |