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 CP IMPELLA CP PUMP SET EU 0048-0002 manufactured by Abiomed Europe Gmbh.
[183082762]
The impella cp and data logs were returned for evaluation. Data logs found the device did not encounter ta pump stop, however, low flow and suction was present during use. The device was visually inspected and noted to have a fractured impeller blade. Simulated use testing in a basin of water successfully reproduced the low pump flows as indicated in the data logs. A review of the dhr was conducted and found no manufacturing issues or reworks associated with this pump lot. There are no other complaints related to this failure mode associated with pumps in this lot. Due to lack of clinical data, we can not definitively determine the cause of the damaged impeller blades.
Patient Sequence No: 1, Text Type: N, H10
[183082763]
The complainant reported a patient of unknown age, gender, or race presenting for hemodynamic support using the impella cp device. The complainant reported pump stopping immediately after initiation and could not be restarted. The pump was removed and replaced without any adverse impact to the patient. The device was returned and broken impeller blades were identified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2020-00372 |
| MDR Report Key | 9814430 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-28 |
| Date Facility Aware | 2020-02-28 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2019-12-16 |
| 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 MA 01923 |
| Manufacturer Country | US |
| Manufacturer Postal | 01923 |
| Manufacturer G1 | ABIOMED EUROPE GMBH |
| Manufacturer Street | NEUENHOFER WEG 3 |
| Manufacturer City | AACHEN 52074 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 52074 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPELLA CP |
| Generic Name | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP |
| Product Code | OZD |
| Date Received | 2020-03-10 |
| Returned To Mfg | 2020-02-03 |
| Model Number | IMPELLA CP PUMP SET EU |
| Catalog Number | 0048-0002 |
| Lot Number | 1455279 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABIOMED EUROPE GMBH |
| Manufacturer Address | NEUENHOFER WEG 3 AACHEN 52074 GM 52074 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-10 |