BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARVEST TERUMO

    MDR report key: 6450401 · Received March 31, 2017

    Report

    Report Number
    1722028-2017-00103
    Event Type
    Malfunction
    Date Received
    March 31, 2017
    Date of Event
    September 13, 2016
    Report Date
    March 31, 2017
    Manufacturer
    TERUMO BCT
    Product Code
    JQC
    PMA / PMN Number
    K043261
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: FMF. A MACHINE CHECKOUT WAS PERFORMED BY A TERUMO BCT SERVICE TECHNICIAN. UPON VISUAL INSPECTION OF THE DEVICE, IT WAS NOTED THAT THE LID LATCH WAS FOUND OUT OF ALIGNMENT AND THE LID CANNOT CLOSE WITHOUT BEING LATCHED. THE FEET, WINDOW, GASKET, MAGNET PLATE, AND MAGNET WERE REPLACED ON THE DEVICE. THE LID LATCH WAS RE-ALIGNED PER MANUFACTURER'S SPECIFICATION. FUNCTIONAL TESTS WERE SUCCESSFULLY PERFORMED. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A INTERNAL REPORT INDICATES NO FURTHER RELATED ISSUES HAVE BEEN REPORTED FOR THIS DEVICE. ONE YEAR OF SERVICE HISTORY WAS REVIEWED FOR THIS DEVICE WITH NO PROBLEMS IDENTIFIED RELATED TO THE REPORTED CONDITION. ROOT CAUSE: THE ROOT CAUSE OF THE LATCH FAILURE WAS A MISADJUSTED LATCH.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A SMARTPREP CENTRIFUGE LID LATCH WAS NOT FUNCTIONING PROPERLY AND THE DEVICE WAS RETURNED FOR REPAIR AND EVALUATION. UPON EVALUATION OF THE DEVICE, THE TERUMO BCT SERVICE TECHNICIAN NOTED THAT THE CENTRIFUGE LID POPPED OPEN WHILE THE ROTOR WAS STILL SPINNING. THERE WAS NOT A DONOR OR PATIENT INVOLVED AT THE TIME OF THE INCIDENT, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230800 HARVEST TERUMO SMARTPREP 3-115V JQC TERUMO BCT SMP311500

    Patients

    Seq Age Sex Outcome Treatment
    1 Other