MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-10 for IMPELLA 5.0 PUMP IMPELLA 5.0 PUMP SET, JAPAN 005066-JP manufactured by Abiomed, Inc..
[183082920]
The impella 5. 0 was returned and an investigation is currently underway. A supplemental mdr will be filed with the results of the investigation, upon completion.
Patient Sequence No: 1, Text Type: N, H10
[183082921]
The complainant reported a (b)(6) japanese male patient had impella 5. 0 pump inserted in the right axillary for post-cardiotomy? Cardiogenic shock? (pccs). It was reported the physician suspected hemolysis. The initial position of the pump was verified by echo. The physician attempted to re-position the impella; however, this did not resolve the issue. Continuous hemofiltration/hemodiafiltration (chdf) was started to treat the patient and the impellas position was re-adjusted. The physician stated the patient underwent aortic valve replacement (avr) and mitral valve repair (mvr) surgery, due to this the position of the aortic valve was different from that of a normal patient; therefore, hemolysis was likely to occur.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2020-00371 |
| MDR Report Key | 9814422 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-11 |
| Date Facility Aware | 2020-02-11 |
| Date Mfgr Received | 2020-02-11 |
| Device Manufacturer Date | 2019-03-04 |
| Date Added to Maude | 2020-03-10 |
| 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 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 PUMP |
| Generic Name | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP |
| Product Code | OZD |
| Date Received | 2020-03-10 |
| Returned To Mfg | 2020-03-02 |
| Model Number | IMPELLA 5.0 PUMP SET, JAPAN |
| Catalog Number | 005066-JP |
| Lot Number | 1397086 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-10 |