BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC CENTRIMAG MOTOR

    MDR report key: 7130930 · Received December 19, 2017

    Report

    Report Number
    2916596-2017-03198
    Event Type
    Injury
    Date Received
    December 19, 2017
    Date of Event
    November 20, 2017
    Report Date
    April 19, 2018
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    KFM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT OF AN M4 ALERT WAS CONFIRMED THROUGH THE ANALYSIS OF THE LOG FILE RETRIEVED FROM THE RETURNED PRIMARY CONSOLE. ON (B)(6) 2017 AT 16:31:48, THE MOTOR ALARM:M4 ALERT OCCURRED AND REMAINED ACTIVE AS INTENDED UNTIL THE END OF THE LOG FILE. THE RETURNED PRIMARY CONSOLE, MOTOR, AND FLOW PROBE WERE VISUALLY INSPECTED AND THE MOTOR CABLE WAS FOUND TO BE TWISTED AND WAS NOT IN GOOD WORKING CONDITION. THE RETURNED PRIMARY CONSOLE, MOTOR, AND FLOW PROBE WERE THEN CONNECTED TO AN IN-HOUSE TEST PUMP. THE SYSTEM WAS OPERATED FOR 2 CONSECUTIVE DAYS BASED ON THE OPERATING SPEED RECORDED IN THE LOG FILE AND FUNCTIONED AS INTENDED; HOWEVER, AS SOON AS THE MOTOR CABLE WAS BENT SLIGHT, THE MOTOR ALARM:M4 ALERT OCCURRED, CONSISTENT WITH THE REPORTED EVENT. THE ALARM CLEARED AS INTENDED WHEN THE MUTE BUTTON WAS PRESSED. DAMAGE TO THE INTERNAL WIRES OF THE MOTOR CABLE COULD HAVE POTENTIALLY RESULTED IN THE OBSERVED MOTOR ALARM:M4 ALERT CAPTURED IN THE LOG FILE, AND APPEARED TO BE THE RESULT OF NORMAL WEAR AND TEAR CONSISTENT WITH OVER 2 YEARS OF USE IN THE FIELD. REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE PATIENT¿S AGE AND WEIGHT WERE NOT PROVIDED. DEVICE UNIQUE IDENTIFIER (UDI) ¿ (B)(4). CONCOMITANT MEDICAL PRODUCTS: PRIMARY CONSOLE: SERIAL NUMBER (B)(4), MANUFACTURE DATE: 01JAN2016; FLOW PROBE: SERIAL NUMBER (B)(4), MANUFACTURE DATE: 01OCT2015. THE MOTOR IS NOT A SINGLE USE DEVICE. APPROXIMATE AGE OF THE DEVICE IS 2 YEARS, 3 MONTHS (CALCULATED FROM THE MANUFACTURE DATE OF THE MOTOR). THE DEVICES ARE EXPECTED TO BE RETURNED FOR ANALYSIS. THEY HAVE NOT YET BEEN RECEIVED. THE EVENT OCCURRED AT FREEMAN HOSPITAL, UK. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT ON (B)(6) 2017. IT WAS REPORTED THAT ON (B)(6) 2017, FIVE MINUTES AFTER OXYGENATOR REPLACEMENT, AN ERROR "M4" OCCURRED ON THE PRIMARY CONSOLE AND THE PUMP STOPPED. THE PATIENT WAS SWITCHED TO BACKUP EQUIPMENT. REPORTEDLY, THE PATIENT WAS NOT INJURED DUE TO THE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911282 THORATEC CENTRIMAG MOTOR CENTRIMAG MOTOR KFM THORATEC SWITZERLAND GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R