MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-19 for IMPELLA CP OPTICAL IMPELLA CP PUMP 371 SET, US 0048-0024 manufactured by Abiomed, Inc..
[184262080]
The impella cp was not returned 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
[184262081]
The complainant reported a (b)(6) white male patient presenting with acute myocardial infarction and cardiogenic shock for hemodynamic support with the impella cp optical device. During support, the patient exhibited signs of hemolysis via hemolyzed labs, however, no plasma-free hemoglobin tests were performed to confirm. Approximately 6 hours into support, the impella was rapidly weaned in response to the suspected hemolysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2020-00387 |
| MDR Report Key | 9857145 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-01-19 |
| Date Facility Aware | 2020-01-19 |
| Date Mfgr Received | 2020-01-19 |
| Device Manufacturer Date | 2019-11-15 |
| Date Added to Maude | 2020-03-19 |
| 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 |
| Generic Name | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP |
| Product Code | OZD |
| Date Received | 2020-03-19 |
| Model Number | IMPELLA CP PUMP 371 SET, US |
| Catalog Number | 0048-0024 |
| Lot Number | 1445555 |
| 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 | 2020-03-19 |