BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRIMAG MOTOR, US

    MDR report key: 12732028 · Received November 1, 2021

    Report

    Report Number
    3003306248-2021-05700
    Event Type
    Malfunction
    Date Received
    November 1, 2021
    Date of Event
    October 5, 2021
    Report Date
    May 9, 2022
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    KFM
    UDI-DI
    07640135140078
    PMA / PMN Number
    K020271
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE PUMP VIBRATING, AND A LOUD NOISE WAS CONFIRMED. THE CENTRIMAG MOTOR (SERIAL #: (B)(6)) WAS RETURNED FOR ANALYSIS TO THE SERVICE DEPOT. THE MOTOR WAS TESTED WITH THE RETURNED AND ASSOCIATED CENTRIMAG 2ND GENERATION PRIMARY CONSOLE AS WELL AS A TEST CONSOLE AND MOCK LOOP. THE REPORTED EVENT WAS DUPLICATED AND WAS ISOLATED TO THE MOTOR. WHEN THE MOTOR CABLE WAS TILTED OR WHEN THE CONSOLE WAS MOVED UP AND TO THE LEFT, THE PUMP WOULD JUMP AND FLUTTER. THE MOTOR WAS FORWARDED TO ZURICH FOR FURTHER REVIEW. AN ENGINEERING INVESTIGATION WAS PERFORMED AND DETERMINED THAT THERE WAS A BAD CONNECTION INSIDE THE MOTOR'S LEMO CONNECTOR WAS FOUND AT ITS PIN #6. THE BAD CONNECTION WAS EITHER CAUSED BY A BAD SOLDERING JOINT, OR/AND BECAUSE THE WIRE ITSELF HAS BROKEN (POSSIBLY CAUSED BY A CUT DURING REMOVING THE WIRE-INSULATION PERFORMED BY THE MANUFACTURER KUK BEFORE WIRE-SOLDERING). THE BAD CONNECTION AFFECTED THE SIGNAL LINE HALL "HX". A MANUFACTURING ANALYSIS TASK WAS PERFORMED. IT WAS FOUND THAT THE BAD CONNECTION IN THE LEMO CONNECTOR COULD BE DUE TO IMPROPER CABLE ASSEMBLY AT THE SUPPLIER KUK ELECTRONICS. A SCAR WAS INITIATED TO INFORM THE SUPPLIER. THE ROOT CAUSE FOR THE REPORTED EVENT WAS CONCLUSIVELY DETERMINED TO BE DUE TO A SOLDER JOINT ISSUE IN THE MOTOR CABLE LEMO CONNECTOR. 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. M) 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. M) 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. M) SECTION 8.2 ENTITLED ¿CONSOLE ALARM/ALERT STRATEGY¿ STATES ¿IF AN ALARM OR ALERT CONDITION OCCURS, THE AUDIBLE ADVISORY SOUNDS ALONG WITH A VISUAL MESSAGE INDICATING THE CAUSE(S) OF THE ALARM/ALERT CONDITION ON THE ALPHANUMERIC DISPLAY. DEPRESSING THE ALARM ACKNOWLEDGE KEYPAD TEMPORARILY MUTES THE AUDIBLE ALARM FOR MOST ALARMS AND THE AUDIO PAUSED SYMBOL IS DISPLAYED ON THE CONSOLE AND THE MONITOR¿. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    NO PATIENT INVOLVED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE NUMBER: 3003306248-2021-05701. IT WAS REPORTED THAT UPON SEATING CUSTOMERS' PRIMED DEMO LOOP IN THE MOTOR, THE IMPELLER VIBRATED WITHIN THE PUMP HOUSING, ASSOCIATED WITH A LOUD NOISE. THERE WAS NO ALARM. THE CUSTOMERS' DEMO LOOP WERE REMOVED AND THE DEMO PUMP WAS SEATED WITH THE SAME RESULT. THAT TIME, A MOTOR STOPPED ALARM APPEARED ON THE CONSOLE WITH NO AUDIO ALARM. THE CABLES AND PINS OF THE MOTOR CABLE WERE INSPECTED VISUALLY, AND APPEARED TO BE INTACT. THE CONSOLE WAS TURNED OFF AND RECONNECTED TO THE MOTOR. THE CONSOLE WAS TURNED BACK ON AND THERE WERE NO FURTHER ISSUES. DUE TO THE INITIAL UNEXPECTED MOTOR ISSUE WITH NO ALARMS AND NO DISCERNABLE RATIONALE, THE DEVICE WOULD BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1626984 CENTRIMAG MOTOR, US PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM THORATEC SWITZERLAND GMBH 102956 7426862 07640135140078

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown