BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCRON

    MDR report key: 2061802 · Received April 11, 2011

    Report

    Report Number
    2061802
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 11, 2011
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    WE WERE DOING A VASCULAR CASE WITH THE DOCTOR AND NEEDED TO USE THE HEMOCHRON MACHINE. THE RESULTS CAME BACK UNUSUALLY HIGH ACCORDING TO THE DOCTOR. HE THEN ASKED US TO RETEST. THE RESULTS ALSO CAME BACK HIGH. THEN THE DOCTOR ASKED US IF THE MACHINE HAD BEEN CALIBRATED THAT DAY. WE VERIFIED WITH THE CHARGE NURSE THAT IT HAD BEEN CALIBRATED THAT DAY. WE BORROWED ANOTHER HEMOCHRON FROM ANOTHER DEPARTMENT. THE SECOND MACHINE OPERATED WITHIN NORMAL PARAMETERS AND WE WERE ABLE TO PROCEED WITH OUT INCIDENT. THE MALFUNCTIONING HEMOCHRON MACHINE WAS IMMEDIATELY REMOVED FROM SERVICE AND SENT TO BIOMED FOR REPAIR.BIOMED COMMENTS: I DID CHECK THE HEMOCHRON UNIT ACCORDINGLY WITH THE MANUFACTURER INSTRUCTIONS. THE ONLY TWO WAYS TO TEST THE UNIT IT IS USING THE EQC AND THE LIQUID QC THAT IT IS SUPPOSED TO BE DONE BY THE POC ON THEIR OWN DAILY OR WEEKLY SCHEDULE. THE UNIT PASSED THE EQC THAT I DID. THIS EQC WILL TEST ALL THE MECHANICAL AND ELECTRICAL CIRCUITS IN THE UNIT. THE UNIT WAS PUT BACK INTO OPERATION. NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCRON HEMOCRON JPA INTERNATIONAL TECHNIDYNE CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR