BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE ADMINISTRATION SET

    MDR report key: 6365854 · Received February 28, 2017

    Report

    Report Number
    9616066-2017-00353
    Event Type
    Malfunction
    Date Received
    February 28, 2017
    Report Date
    February 10, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF A HOLE IN THE TUBING WAS CONFIRMED. VISUAL INSPECTION OBSERVED THAT THE SILICONE SEGMENT HAD A TEAR NEAR THE UPPER FITMENT. THE TEAR MEASURED 0.058 INCHES LONG. VISUAL EXAMINATION UNDER MAGNIFICATION NOTED NO CRUSH MARK TO THE UPPER BLUE FITMENT. FUNCTIONAL AND PRESSURE TESTING WAS PERFORMED; A LEAK WAS OBSERVED COMING OUT FROM THE SILICONE TUBING NEAR THE UPPER FITMENT. THE CAUSE OF THE LEAK WAS A TEAR IN THE SILICONE SEGMENT. THE ROOT CAUSE OF THE TEAR WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4), LOT: 16125108 IS 07613203021012. CONCOMITANT MEDICAL PRODUCTS: 250 ML BAXTER BAG NDC 0338-0049-02, LOT Y221309, EXP JUL 18, 09.% SODIUM CHLORIDE INJECTION; THERAPY DATE UNKNOWN THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE PRIMING LEVOPHED THAT WAS CONNECTED TO THE PATIENT, THEY NOTICED FLUID DRIPPING ON THE FLOOR. AFTER LOOKING AT THE TUBING THEY FOUND A HOLE IN THE TUBING AND THE MEDICATION WAS LEAKING FROM IT. THERE IS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149082 ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2420-0007 16125108

    Patients

    Seq Age Sex Outcome Treatment
    1