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 2020-03-26 for IMPELLA 5.0 IMPELLA 5.0 PUMP SET, JAPAN 05066-JP manufactured by Abiomed, Inc..
[185477376]
The impella 5. 0 was received (b)(6) 2019 under complaint case-(b)(4) under a different symptom that was assessed as not reportable. The original complaint was closed, however, the customer has reported new information pertaining to a new symptom (hemolysis). Thus, a new complaint record was opened. Upon evaluation of this device for the newly reported symptom, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[185477377]
The complainant reported a (b)(6) asian male presenting for hemodynamic support with the impella 5. 0 device. During support, the patient exhibited clinical signs of hemolysis via tests for hemoglobin, total bilirubin, and ldh. Plasma-free hemoglobin was not tested, thus, we cannot definitively confirm the patient's hemolysis. As treatment, several units of blood products were delivered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2020-00392 |
| MDR Report Key | 9886990 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2019-11-15 |
| Date Facility Aware | 2020-03-03 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2018-09-04 |
| 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 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 5.0 |
| Generic Name | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP |
| Product Code | OZD |
| Date Received | 2020-03-26 |
| Returned To Mfg | 2019-12-04 |
| Model Number | IMPELLA 5.0 PUMP SET, JAPAN |
| Catalog Number | 05066-JP |
| Lot Number | 1359038 |
| 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 | 2020-03-26 |