BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CENTRIFUGAL SYSTEM

    MDR report key: 4152457 · Received October 6, 2014

    Report

    Report Number
    1828100-2014-00813
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 12, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    KFM
    PMA / PMN Number
    K902198
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED. THE BIOMED CHARGED THE BATTERIES FOR TWO DAYS, THEN RAN TEST 1:45 BATTERY RUN. THE BATTERIES ONLY LASTED FORTY-FIVE MINUTES. THE BATTERIES WERE CHANGED ON (B)(4) 2014. THE BIOMED REPLACED THE SUSPECT BATTERIES WITH NEW BATTERIES. THE NEW BATTERIES LASTED THE FULL NINETY MINUTES AS REQUIRED BY THE PREVENTATIVE MAINTENANCE (PM) PROCEDURE. THE SUSPECT BATTERIES WERE RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION.

    Description of Event or Problem · 1

    THE USER FACILITY'S BIOMEDICAL ENGINEER (BIOMED) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THE BATTERIES ARE NOT LASTING AS EXPECTED ON THE CENTRIFUGAL SYSTEM. SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE, THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622152 TERUMO CENTRIFUGAL SYSTEM SARNS CENTRIFUGAL SYSTEM KFM TERUMO CARDIOVASCULAR SYSTEMS CORP. 9490

    Patients

    Seq Age Sex Outcome Treatment
    1