BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLOTTING FACTOR V DEFICIENT PLASMA

    MDR report key: 9830450 · Received March 13, 2020

    Report

    Report Number
    9610806-2020-00009
    Event Type
    Malfunction
    Date Received
    March 13, 2020
    Date of Event
    February 13, 2020
    Report Date
    April 15, 2020
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GJT
    PMA / PMN Number
    K924394
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 9610806-2020-00009 ON 13-MAR-2020. ADDITIONAL INFORMATION (19-MAR-2020): SIEMENS HAS DETERMINED THAT THERE IS NO RISK TO HEALTH AS A RESULT OF THE CLOTTING FACTOR V DEFICIENT PLASMA VIALS (CATALOG NUMBER: 10446269 , LOT NUMBER: 504974) HAVING A HIGHER FACTOR V CONCENTRATION THAN WOULD BE EXPECTED. THE INCORRECT VIALS WILL LEAD TO QUALITY CONTROL (QC) RESULTS RECOVERING OUT OF RANGE. ADDITIONAL INFORMATION (23-MAR-2020): SIEMENS' INVESTIGATION HAS DETERMINED THAT THE CAUSE OF A HIGHER FACTOR V CONCENTRATION THAN WOULD BE EXPECTED WITH THE CLOTTING FACTOR V DEFICIENT PLASMA LOT NUMBER 504974 WAS DUE TO HUMAN ERROR DURING THE MANUFACTURING PROCESS. ONE BOX CONTAINING 288 VIALS OF PT MULTI CALIBRATOR LEVEL 3 (LOT NUMBER: 555393) WAS LOADED INTO THE FREEZE DRYER WHERE VIALS OF FACTOR V DEFICIENT PLASMA (LOT NUMBER: 504974) WERE LOCATED AND WERE INCLUDED IN THE KITTING OF CLOTTING FACTOR V DEFICIENT PLASMA KITS FOR LOT NUMBER 504974. THERE IS NO POTENTIAL FOR AN ERRONEOUS PATIENT RESULT. THE CLOTTING FACTOR V DEFICIENT PLASMA, WHICH IS DISTRIBUTED IN THE UNITED STATES UNDER CATALOG NUMBER 10446271, IS NOT AFFECTED BY THIS ISSUE AND IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE AFFECTED PRODUCT (CLOTTING FACTOR V DEFICIENT PLASMA, CATALOG NUMBER: 10446269, LOT NUMBER: 504974) IS NOT DISTRIBUTED IN THE UNITED STATES. THIS MDR IS BEING FILED FOR SIMILAR PRODUCT. CLOTTING FACTOR V DEFICIENT PLASMA IS DISTRIBUTED IN THE UNITED STATES UNDER CATALOG NUMBER (10446271). SIEMENS IS INVESTIGATING THE ISSUE.

    Description of Event or Problem · 1

    SIEMENS PERSONNEL OBSERVED THAT SEVERAL CLOTTING FACTOR V DEFICIENT PLASMA VIALS (LOT NUMBER: 504974) HAD A HIGHER FACTOR V CONCENTRATION THAN WOULD BE EXPECTED. OUT OF 30 VIALS, 5 OF THE VIALS HAD A FACTOR V CONCENTRATION BETWEEN 72.4% AND 76%, INSTEAD OF <5% WHICH IS EXPECTED. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294884 CLOTTING FACTOR V DEFICIENT PLASMA CLOTTING FACTOR V DEFICIENT PLASMA GJT SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH SEE SECTION H10

    Patients

    Seq Age Sex Outcome Treatment
    1