MAUDE Adverse Event Report: THORATEC CORPORATION / ABBOTT LABORATORIES CENTRIMAG ECMO PUMP CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY, BYPASS

Model Number 201-303000 UNIT

Device Problems Device Alarm System (1012); Defective Component (2292); Appropriate Term/Code Not Available (3191); Noise, Audible (3273)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 11/06/2019

Event Type  Injury  

Event Description

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).

• Brand Name: CENTRIMAG ECMO PUMP CONSOLE
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY, BYPASS
• Manufacturer (Section D): THORATEC CORPORATION / ABBOTT LABORATORIES
• MDR Report Key: 9543226
• MDR Text Key: 173744540
• Report Number: MW5092010
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/31/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-303000 UNIT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/02/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 19 YR
• Patient Weight: 52