BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 3902631 · Received May 9, 2014

    Report

    Report Number
    2249723-2014-00561
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Report Date
    July 17, 2013
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PERFORMS PREVENTIVE MAINTENANCE AND SVC ON THESE IABP PUMPS. THE CUSTOMER REPLACED THE DRIVE MANIFOLD ASSEMBLY (P/N: 0104-00-0018). THE MANUFACTURER COMPLETED AN EVAL ON THE DRIVE MANIFOLD RETURNED FROM THIS CUSTOMER FACILITY. THE COMPANY INVESTIGATION CONFIRMED THAT THE DRIVE MANIFOLD FAILURE WERE CAUSED BY A 'STICKY' K6 VALVE. A COMP INVESTIGATION DETERMINED THAT THE UNDERLYING CAUSE OF K6 'STICKY' FAILURES WAS THE COIL POWER: THE COIL REQUIRED MORE POWER THAT THE SOLENOID DRIVER BOARD COULD DELIVER TO MOVE THE PLUNGER; ADDITIONALLY, THE SUPPLIER WAS NOT TESTING (DRIVING) THE K6 VALVE AS DESIGNED IN THE CS100/CS300 IABP. THE SUPPLIER TESTED THE VALVE USING UNREGULATED CURRENT AT 24V WITHOUT ANY MODULATION OR CURRENT LIMITING. THE COMPANY TOOK THE FOLLOWING ACTIONS: PERFORMED HEALTH HAZARD EVAL (HHE): THE HHE CONCLUDED THAT THE OVERALL PT RISK FOR THE REPORTED MALFUNCTION (DRIVE MANIFOLD-P/N 0104-00-0018 'STICKY' K6) IS LOW; OPENED A CORRECTIVE ACTION WITH REMEDIAL ACTIONS (CAPA): ADD A K6 'STICKY' SCREEN TO MANUFACTURING TEST PROCESS. SUPPLIED A TEST FIXTURE TO THE VENDOR TO ACTIVATE THE MANIFOLD VALVES SIMILARLY TO THE WAY IT IS DONE IN A CS100/CS300 IABP (PULSED AND CURRENT LIMITED). RELATED CS300S - SERIAL NUMBER (B)(4), MDR 2249723-2014-549; (B)(4), MDR 2249723-2014-550. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THREE TIMES IN THE PAST 18 MONTHS HE HAD TO REPLACE THE DRIVE ASSEMBLY ON THREE DIFFERENT CS300'S BECAUSE K6 WAS STICKING WHICH CAUSED AUTOFILL ERRORS. HE WAS UNSURE IF ALL THREE WERE ON A PT WHEN THE ERRORS OCCURRED. THE TIME BETWEEN EACH USE FOR ALL 3 IABP'S IS NOT KNOW. THE SERIAL NUMBERS FOR THE OTHER TWO CS300'S ARE: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282300 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP CS300

    Patients

    Seq Age Sex Outcome Treatment
    1