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

Model Number 102956

Device Problem Insufficient Information (3190)

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

Event Date 12/28/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the centrimag displayed motor disconnect and pump not inserted errors.The motor would be returned for evaluation.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of motor alarms was confirmed.The centrimag motor (serial #: (b)(6) was returned for analysis to the service depot.The reported event of a ¿motor disconnected: m2¿ and ¿pump not inserted: m3¿ alarm was confirmed.The motor was connected to a test console and the motor was not recognized.A m2 alarm was active.The alarm was unable to be cleared and this behavior was reproduced on a second test console.The motor was scrapped and forwarded to product performance engineering (ppe) for further analysis.Upon further analysis with ppe, the motor was connected to a calibrated console, monitor, flow probe and test blood pump and mock loop.A m2 alarm was active but cleared with manipulation of the motor cable at the motor end bend relief.The speed was able to be increased; however, ¿motor alarm: m4¿ activated occasionally.While active, the pump would rattle.The m4 alarm would clear when the motor cable was manipulated near the motor end bend relief.The motor cable underwent a resistance and insulation test.During the resistance test, the motor cable had an open lead on the a2+/a2- line.The motor cable passed the insulation test.The motor cable was opened near the motor end bend relief and a breach in the insulation of a1- (yellow wire).Additionally, a2- (red wire) was found to be kinked.The insulation was removed, and the conductor was severed.Multiple good faith efforts were sent to retrieve additional information regarding if there was patient involvement and if any troubleshooting was performed; however, no response was received.The root cause for the reported event was conclusively determined to be due to wire fatigue 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 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 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 section 12.1 ¿appendix i ¿ console alarms and alerts¿ table 16 details how to properly interpret and troubleshoot all system alarms including m2, s3, f2, and f3 alarms.No further information was provided.The manufacturer is closing the file on this event.

• 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 CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 16194156
• MDR Text Key: 307595345
• Report Number: 3003306248-2023-00010
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140078
• UDI-Public: 07640135140078
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2023
• 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: 01/06/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2012
• 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