BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARVEST TERUMO

    MDR report key: 5079779 · Received September 15, 2015

    Report

    Report Number
    1722028-2015-00550
    Event Type
    Malfunction
    Date Received
    September 15, 2015
    Date of Event
    August 12, 2015
    Report Date
    August 21, 2015
    Manufacturer
    TERUMO BCT
    Product Code
    JQC
    PMA / PMN Number
    K052925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: FMF INVESTIGATION: THE MACHINE WAS CHECKED OUT BY A TERUMO BCT SERVICE TECHNICIAN. TECHNICIAN POWERED THE MACHINE ON AND IT RAN NORMALLY. THE LID LATCH WAS REALIGNED AND THE MAGNET PLATE WAS REPLACED. THE MACHINE PASSED A LID LATCH TEST RUN. DURING TESTING, THE MACHINE INTERMITTENTLY STOPPED BY ITSELF. THE DISPLAY BOARD WAS FOUND TO HAVE A BAD STOP SWITCH. THE DISPLAY BOARD WAS REPLACED AND ALL FUNCTIONAL TESTS WERE REPEATED SUCCESSFULLY. THE FEET WERE REPLACED AND THE MACHINE CLEANED. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE DISPLAY BOARD WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION REVEALED NO ANOMALIES. AN INSPECTION OF THE STOP SWITCH FOUND S3 TO INTERMITTENTLY DISCONNECT WHEN PRESSED. THE TECHNICIAN WAS ABLE TO DUPLICATE THE ISSUE THAT COULD LEAD TO THE REPORTED PROBLEM. ONE YEAR OF SERVICE HISTORY WAS REVIEWED FOR THIS DEVICE WITH NO PROBLEMS IDENTIFIED THAT WERE RELATED TO THE REPORTED CONDITION. AN INTERNAL REPORT INDICATES NO FURTHER RELATED ISSUES HAVE BEEN REPORTED FOR THIS DEVICE. ROOT CAUSE: THE ROOT CAUSE OF THIS FAILURE WAS A FAULTY DISPLAY BOARD AND MISADJUSTED LID LATCH. CORRECTIVE AND PREVENTATIVE ACTION: AN INTERNAL CAPA HAS BEEN INITIATED TO ADDRESS LATCH MECHANISM ISSUES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A SMARTPREP CENTRIFUGE WAS NOT FUNCTIONING PROPERLY AND A SERVICE CALL WAS INITIATED TO EVALUATE THE DEVICE. UPON EVALUATION OF THE DEVICE, THE TERUMO BCT SERVICE TECHNICIAN NOTED THAT THE CENTRIFUGE LID POPPED OPEN WHEN 'STOP' WAS PRESSED ON THE DEVICE AND 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
    610189 HARVEST TERUMO SMARTPREP 2-115V JQC TERUMO BCT SMP211501

    Patients

    Seq Age Sex Outcome Treatment
    1 Other