MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 102956

Device Problems Decreased Pump Speed (1500); Vibration (1674)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/21/2018

Event Type  malfunction  

Manufacturer Narrative

Information was not provided.Approximate age of device - the motor is not a single use device.The approximate age of the device is 4 years, 1 month, calculated from the date of manufacture.The returned centrimag motor was evaluated and tested and it was confirmed that the returned motor was defective.When the motor was connected to a test centrimag 2nd gen console the console displayed a "motor disconnected:m2" message, even after numerous attempts.The motor was never detected by the console.As a result, the report of vibrations and speed changes could not be confirmed.Continuity testing of the motor cable revealed an intermittent open connection in the input current bearing phase b2 (ib2+ line) and the output current bearing phase b2 (ib2-).When the motor cable was manipulated near the motor end bend relief the resistance value would change, indicating that the issue was a result of conductor breakdown in the motor cable.Although the root cause of this breakdown could not be conclusively determined, it appeared to be a result of repetitive bending or twisting of the motor cable during use.A review of the device history records revealed the device met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported by the perfusionist that the centrimag motor was not functioning properly and the motor was vibrating.The perfusionist was not sure if it was a magnet issue but according to the bio-medical engineer, they could physically see the pump change it's speed and hear a slight noise when this happened.The device was not in use supporting a patient at the time.

• Brand Name: CENTRIMAG MOTOR, US
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 8064719
• MDR Text Key: 128060801
• Report Number: 2916596-2018-04918
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140078
• UDI-Public: 07640135140078
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 102956
• Device Catalogue Number: 102956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: FA-Q318-MCS-1
• Patient Sequence Number: 1