BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE ADMINISTRATION SET

    MDR report key: 8341713 · Received February 14, 2019

    Report

    Report Number
    9616066-2019-00324
    Event Type
    Malfunction
    Date Received
    February 14, 2019
    Date of Event
    December 3, 2018
    Report Date
    January 18, 2019
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    10885403228018
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: NON BD SET AND ONE USED 5ML EXCELSIOR MEDICAL SYRINGE LOT 3133243 EXP 2020-05-01 0.9% SODIUM CHLORIDE INJECTION; THERAPY DATE (B)(6) 2018. ALTHOUGH REQUESTED, NO INFORMATION RECEIVED. THE CUSTOMER¿S REPORT OF A LEAK WAS CONFIRMED. FUNCTIONAL TESTING FOUND THE SET LEAKED FROM THE TOP OF THE SILICONE SEGMENT. CLOSER INSPECTION UNDER MAGNIFICATION OBSERVED A LEAK FROM A SMALL HOLE ON THE SILICONE SEGMENT. NO TOOL MARKS OR CRUSH MARKS WERE OBSERVED ON THE UPPER FITMENT NEAR THE SMALL HOLE. THE SOURCE OF THE LEAK IS A SMALL HOLE/DAMAGE IN THE SILICONE PUMP SEGMENT NEAR THE UPPER FITMENT. THE ROOT CAUSE OF THE HOLE/DAMAGE COULD NOT BE DEFINITIVELY DETERMINED.

    Description of Event or Problem · 1

    THE SET WAS RECEIVED UNEXPECTEDLY WITH A REPORT THAT IT LEAKED, POTENTIALLY FROM A CRACK OR FLUSH. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132293 ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2429-0500 10885403228018

    Patients

    Seq Age Sex Outcome Treatment
    1 23 MO