BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARVEST TERUMO

    MDR report key: 5011209 · Received August 18, 2015

    Report

    Report Number
    1722028-2015-00493
    Event Type
    Malfunction
    Date Received
    August 18, 2015
    Date of Event
    July 24, 2015
    Report Date
    July 24, 2015
    Manufacturer
    TERUMO BCT
    Product Code
    JQC
    PMA / PMN Number
    K052925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: AN INTERNAL REPORT OF PROCEDURES AT THIS SITE SHOWS THAT THE MACHINE HAS BEEN IN USE WITH NO FURTHER OCCURRENCES OF THE PROBLEM. ROOT CAUSE: THE ROOT CAUSE OF THIS FAILURE WAS A MISADJUSTED LID LATCH. CORRECTIVE ACTION: AN INTERNAL CAPA HAS BEEN INITIATED TO ADDRESS LATCH MECHANISM ISSUES.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: FMF. INVESTIGATION: THE MACHINE WAS RETURNED TO TERUMO BCT FOR REPAIR AND INVESTIGATION. A SERVICE TECHNICIAN VISUALLY INSPECTED THE DEVICE AND CONFIRMED THAT THE LID LATCH WAS OUT OF ADJUSTMENT. THE LID LATCH WAS REALIGNED. A SIMULATED USE TEST WAS PERFORMED AND CONFIRMED THAT THE LID STAYED CLOSED THROUGH THE FULL CYCLE. THE MACHINE IS FUNCTIONING WITHIN SPECIFICATION. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE LAST YEAR OF SERVICE HISTORY FOR THIS DEVICE INDICATED NO OTHER REPORTS RELATED TO THIS ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PROCEDURE, THE LID OF A SMARTPREP CENTRIFUGE WOULD NOT STAY CLOSED. THE PROCEDURE COULD NOT BE COMPLETED UNLESS THE LID WAS HELD DOWN MANUALLY. THERE WAS NOT A DONOR OR PATIENT INVOLVED AT THE TIME OF THE PROCEDURE, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546004 HARVEST TERUMO SMARTPREP 2-115V JQC TERUMO BCT SMP211501

    Patients

    Seq Age Sex Outcome Treatment
    1 Other