MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Device Problems Temperature Problem (3022); Noise, Audible (3273)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 11/09/2018

Event Type  malfunction  

Event Description

Pt is on centrally cannulated va ecmo via centrimag.Writer entered room because i heard a loud "whirring" noise; immediately realized it was the motor pump of the ecmo.This motor pump was also very hot to the touch.I alerted perfusion, cca, and my charge nurse.Perfusion came to the bedside, and we switched out the motor head.This is unsafe for the pt because he relies on ecmo and his blood pressure drops into the 30's during pump changes.Manufacturer response for "centramag" "echmo" device, (brand not provided) (per site reporter).The manufacturer is investigating what happened.

• Brand Name: CENTRIMAG
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; 6035 stoneridge dr; pleasanton CA 94588
• MDR Report Key: 8178918
• MDR Text Key: 130924514
• Report Number: 8178918
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/12/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26645 DA