BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFUSOR

    MDR report key: 1841305 · Received September 16, 2010

    Report

    Report Number
    2244861-2010-00001
    Event Type
    Malfunction
    Date Received
    September 16, 2010
    Date of Event
    August 1, 2010
    Report Date
    September 14, 2010
    Manufacturer
    CAS MEDICAL SYSTEMS, INC. (STATCORP)
    Product Code
    KZB
    PMA / PMN Number
    K893519
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    "THE INFORMATION PASSED ON FROM THE DISTRIBUTOR INDICATES THAT THE DEVICE USED IN THE HOSPITAL DID NOT MAINTAIN ITS DESIRED INFLATION PRESSURE FOR THE EXPECTED TIME OF USE. GRADUALLY DECREASING INFLATION PRESSURE LED TO THE OCCLUSION OF A PATIENT'S ARTERIAL LINE AND RESULTED IN THE NEED TO REPLACE THE ARTERIAL LINE. THERE WAS NO ADVERSE EFFECT TO THE PATIENT. THE PRODUCTS GAUGE T-FITTING WAS IDENTIFIED BY VISUAL EXAMINATION AS THE SOURCE OF THE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIFUSOR PRESSURE INFUSOR FOR AN IV BAG KZB CAS MEDICAL SYSTEMS, INC. (STATCORP) 803FGA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other