MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-02 for CENTRIMAG ECMO PUMP CONSOLE 201-303000 UNIT manufactured by Thoratec Corporation / Abbott Laboratories.
[173744540]
Ecmo pump started making mechanical clicking noise. Called perfusionist to discuss. No air or clots visible even with coming down on rpms. Pump settings were at 3700 rpms, blood flow was 4. 2 lpm. Started alarming system 3 error (tempt alarm), perfusionist recommended bringing back up pump and pump head into room in case it fails. After speaking with perfusionist, called md and arnp to bedside and pump started alarming motor head overheating. Decision made to switch pump and pump head before complete failure since pt has no reserve. Pt hr dropped to 30s during switch. Blood pressure drop, dopamine transiently increased to maintain perfusion. Discontinued after pump changed due to systolic blood pressure in the 140s. Pt stabilized with no further sequela; however, this would have been a catastrophic life-threatening event had a back-up pump not been immediately available. Removed pump and pump head from pt care areas. Pump head defective and replaced. Replacement of 3 add'l pump heads requested through mfr. Mfr provided loaner pumps until new parts made available. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092010 |
| MDR Report Key | 9543226 |
| Date Received | 2020-01-02 |
| Date of Report | 2019-12-31 |
| Date of Event | 2019-11-06 |
| Date Added to Maude | 2020-01-03 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | RISK MANAGER |
| 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 | CENTRIMAG ECMO PUMP CONSOLE |
| Generic Name | CONTROL, PUMP SPEED, CARDIOPULMONARY, BYPASS |
| Product Code | DWA |
| Date Received | 2020-01-02 |
| Returned To Mfg | 2019-11-11 |
| Model Number | 201-303000 UNIT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THORATEC CORPORATION / ABBOTT LABORATORIES |
| Brand Name | PUMP HEAD |
| Generic Name | CONTROL, PUMP SPEED, CARDIOPULMONARY, BYPASS |
| Product Code | DWA |
| Date Received | 2020-01-02 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | THORATEC CORPORATION / ABBOTT LABORATORIES |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2020-01-02 |