MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-25 for IMPELLA 0048-0003 manufactured by Abiomed, Inc..
[109254236]
Patient Sequence No: 1, Text Type: N, H10
[109254237]
After placing the impella catheter, blood was backing out of the red connection, making the arterial waveform and pressure inaccurate. The pump continued to perform correctly so the impella stayed in the patient for 48 hours. No harm to patient upon removal. Manufacturer response for impella catheter, (brand not provided) (per site reporter): device was returned to rep for manufacturer evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7544290 |
| MDR Report Key | 7544290 |
| Date Received | 2018-05-25 |
| Date of Report | 2018-05-14 |
| Date of Event | 2018-05-08 |
| Report Date | 2018-05-14 |
| Date Reported to FDA | 2018-05-14 |
| Date Reported to Mfgr | 2018-05-14 |
| Date Added to Maude | 2018-05-25 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPELLA |
| Generic Name | TEMPORARY CARDIAC SUPPORT BLOOD PUMP |
| Product Code | PBL |
| Date Received | 2018-05-25 |
| Returned To Mfg | 2018-05-14 |
| Model Number | 0048-0003 |
| Lot Number | 140515 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABIOMED, INC. |
| Manufacturer Address | 22 CHERRY HILL DRIVE DANVERS MA 01923 US 01923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-25 |