BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTEM DELTA SYSTEM

    MDR report key: 7261170 · Received February 9, 2018

    Report

    Report Number
    3005792925-2018-00002
    Event Type
    Malfunction
    Date Received
    February 9, 2018
    Date of Event
    January 16, 2018
    Report Date
    May 23, 2018
    Manufacturer
    TEM INNOVATIONS GMBH
    Product Code
    JPA
    UDI-DI
    04260160470020
    PMA / PMN Number
    K101533
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY TECHNICAL SUPPORT VISITED THE SITE AND WAS UNABLE TO REPLICATE THE ISSUE. THIS INCIDENT IS CURRENTLY UNDER INVESTIGATION AND A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A CAPA WAS INITIATED AS PART OF THE INVESTIGATION. ROOT CAUSE IS A DEFECT IN THE SOFTWARE THAT ALLOWS A CLICK BY A USER WITHIN A CERTAIN TIME WINDOW TO ALTER THE ASSOCIATION OF PATIENT DATA FROM ONE SAMPLE TO ANOTHER. A NEW SOFTWARE WAS RELEASED, AND CONFIRMED WITH CORRECTION OF THE DEFECT. NEW SOFTWARE CHANGES THE WAY DATA IS PRESENTED BY USING A PDF VIEWER. THIS METHOD PREVENTS THE ACTIONS FROM THE USER (INADVERTENT CLICKS) FROM ALTERING THE INFORMATION PRESENTED AND THE ASSOCIATION OF THAT INFORMATION WITHIN THE RECORD. THE NEXT STEP OF THE CAPA IS REVIEWING COMPLAINTS AT THE OF JULY AND ENSURING THAT HAS NOT BEEN A RECURRENCE OF THE DEFECT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE ROTEM MERGED THE DEMOGRAPHIC FROM ONE PATIENT WITH THE RESULT OF ANOTHER PATIENT ON THE REPORT. THE PATIENT RESULTS WERE NOT USED FOR TREATMENT AND NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE ROTEM MERGED THE DEMOGRAPHIC FROM ONE PATIENT WITH THE RESULT OF ANOTHER PATIENT ON THE REPORT. THE PATIENT RESULTS WERE NOT USED FOR TREATMENT AND NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104564 ROTEM DELTA SYSTEM WHOLE BLOOD HAEMOSTATIS SYSTEM JPA TEM INNOVATIONS GMBH 04260160470020

    Patients

    Seq Age Sex Outcome Treatment
    1 Other