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

Model Number 201-10002

Device Problem Communication or Transmission Problem (2896)

Patient Problem Not Applicable (3189)

Event Date 10/26/2018

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.The motor is not a single use device.Approximate age of the device - 9 years, 11 months (calculated from the manufacturer date of the motor: november 2008).No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that a "motor not recognized" error message was observed.The device was removed from service pool.No further information was provided.

Manufacturer Narrative

Manufacturer's investigation: the returned centrimag motor (serial number (b)(4)) was evaluated and tested by the service depot under work order #117697.The reported complaint was confirmed and reproduced during testing.During testing, the returned motor was connected to a test 2nd gen primary console.When the console was powered on it displayed an "m2: motor disconnected" message, reproducing the reported issue.Continuity testing of the motor's cable revealed an intermittent open connection in the current drive phase b1 connection (ib1+/ib1- lines) when the cable was manipulated near the motor body bend relief.Although the root cause of this damage could not be conclusively determined, it appeared to be a result of conductor breakdown due to repetitive bending or twisting of the cable during use.It was noted that the motor was manufactured in november 2008, making it over 10 years old.The motor was scrapped due to being defective.Although the root cause of the observed motor cable damage could not be conclusively determined, reports of similar events have been documented and corrective action has been initiated to investigate the issue further.Reports of similar events will continue to be tracked and monitored.Centrimag motor instructions for use (doc.#(b)(4), rev.04) instructs the user to inspect the centrimag motor, cable, console connector, and locking mechanism for any damage prior to use.If any component is damaged, do not use the centrimag motor.This document states that if the unit fails to operate according to the motor specifications or a console diagnostic error indicates a centrimag motor malfunction, it should be returned.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG MOTOR, OUS
• 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
• MDR Report Key: 8075476
• MDR Text Key: 127551832
• Report Number: 2916596-2018-05072
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-10002
• Device Catalogue Number: 201-10002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: FA-Q318-MCS-1
• Patient Sequence Number: 1