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

Model Number 201-10002

Device Problems Mechanical Problem (1384); Device Difficult to Setup or Prepare (1487)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/21/2022

Event Type  malfunction  

Event Description

It was reported that the centrimag motor and blood pump had defective magnetic coupling.Related manufacturer's reference number for the blood pump: 3003306248-2022-00010.

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the motor not functioning as intended was confirmed.The centrimag motor (serial#: (b)(6) was returned for analysis to the european distribution center (edc).The motor cable was tested, and a cable break was found on a1-/a1+ and an open lead was found on a2-/a2+.The motor was scrapped from the system and forwarded to product performance engineering (ppe) for further analysis.Upon further analysis with ppe, the motor was connected to a test console, flow probe, monitor, and blood pump.The motor speed was able to be increased and decreased as intended; however, when the motor cable was manipulated near the motor end bend relief, the pump would stutter and emit an atypical noise due to the stuttering rotation, confirming the reported event.This did not cause the pump to stop.The console was powered on and off and the issue was attempted to be reproduced again; however, now a ¿motor disconnected: m2¿ alarm was activated, indicating that the motor was no longer being recognized.The motor cable underwent a resistance and insulation test, and high resistance was found across all conductors and an open lead was observed on a2-/a2+.The motor cable was stripped near the motor end bend relief.The wires were found to be kinked and the red power line wire was to be broken in multiple places near and under the motor end bend relief.The red wire was soldered back together where it was broken, and the motor was reconnected to the test system.The m2 alarm was cleared, and the stuttering of the pump was unable to be reproduced again.The root cause for the reported event was conclusively determined to be due to wire fatigue of the red power line wire in the motor cable.The device history records were reviewed for the centrimag motor (serial#: (b)(6) and the motor was found to pass all manufacturing and qa specifications.The 2nd generation centrimag system operating manual (rev.L) section 4 entitled "warnings & precautions" warns "one additional 2nd generation centrimag primary console, motor and flow probe are required as backup system in the immediate vicinity of each patient whenever the centrimag or pedivas blood pump is used.The backup console must be connected to the backup motor and to the backup flow probe, have a battery charge sufficient for at least one hour of operation, be connected to ac power (except during transport) and be immediately available should the main console, motor or flow probe experience a malfunction." the 2nd generation centrimag system operating manual (rev.L) section 10 entitled "emergency and troubleshooting" states that "the recommended practice whenever there is a 2nd generation centrimag primary console or motor malfunction is to replace the console and motor as a set.Remove the blood pump from the malfunctioning motor and console and place the blood pump in the backup motor and console to continue patient support.Do not exchange individual motors or individual consoles during patient support." the 2nd generation centrimag system operating manual (rev.L) table 13 entitled ¿console alarms & alerts¿ addresses how to properly interpret and troubleshoot all system alarms including m2 alarms.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
• 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: 13384197
• MDR Text Key: 290542790
• Report Number: 3003306248-2022-00009
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/24/2022

1 Device was Involved in the Event

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: 201-10002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/21/2022
• Initial Date FDA Received: 01/28/2022
• Supplement Dates Manufacturer Received: 05/20/2022
• Supplement Dates FDA Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: FA-Q318-MCS-1
• Patient Sequence Number: 1