BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAPPHIRE¿ INFUSION SET, 1.2 MICRON FILTER, PAV, 123 INCH

    MDR report key: 10011706 · Received April 29, 2020

    Report

    Report Number
    9615050-2020-00059
    Event Type
    Malfunction
    Date Received
    April 29, 2020
    Date of Event
    April 1, 2020
    Report Date
    April 17, 2020
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    MRZ
    UDI-DI
    10887787007449
    PMA / PMN Number
    K171346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE REPORTED COMPLAINT CANNOT BE CONFIRMED WITHOUT THE RETURNED SAMPLE. A DEVICE HISTORY REVIEW (DHR) COULD NOT BE COMPLETED DUE TO THE UNKNOWN LOT NUMBER.

    Description of Event or Problem · 1

    THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A PRIMARY SAPPHIRE¿ INFUSION SET, 1.2 MICRON FILTER, PAV, 123 INCH THAT DURING TESTING, AIR PASSED THROUGH THE FILTER AND DOWN THE LINE. THE CUSTOMER REPORTED THAT THE FILTER DID NOT CATCH THE AIR. THERE WAS NO PATIENT INVOLVEMENT, NO ADVERSE EVENT AND NO DELAY IN CRITICAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472754 SAPPHIRE¿ INFUSION SET, 1.2 MICRON FILTER, PAV, 123 INCH ACCESSORIES, PUMP, INFUSION MRZ ICU MEDICAL COSTA RICA LTD. 1638401 UNKNOWN 10887787007449

    Patients

    Seq Age Sex Outcome Treatment
    1