BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE ADMINISTRATION SET

    MDR report key: 6381073 · Received March 6, 2017

    Report

    Report Number
    9616066-2017-00306
    Event Type
    Malfunction
    Date Received
    March 6, 2017
    Date of Event
    December 8, 2016
    Report Date
    December 16, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 100ML FRESENIUS KABI BAG, NDC 0338-0519-58, LOT 10KE5633, EXP 04/2018, INTRALIPID 20%; THERAPY DATE (B)(6) 2016. THE CUSTOMER¿S REPORT THAT THE TUBING DISCONNECTED FROM THE Y-SITE WAS NOT CONFIRMED HOWEVER DAMAGE WAS NOTED ON THE SPIN COLLAR. VISUAL INSPECTION SHOWED THAT THE MALE LUER SPIN COLLAR HAD THREE HAIR LINE CRACKS WITH LENGTHS OF 0.131, 0.133 AND 0.099 INCHES. THE LUER SHOWED SIGNS OF SCRATCHING AND STRESS AROUND THE CRACKS, COMPARABLE TO THE DAMAGE SEEN WHEN CLAMPS OR TOOLS ARE USED TO TORQUE THE LUER. FUNCTIONAL AND PRESSURE TESTING WAS PERFORMED; NO DISCONNECTIONS OR LEAKS WERE OBSERVED. DIMENSIONAL TESTING WAS PERFORMED AND THE MALE LUER TIP WAS WITHIN SPECIFICATIONS. THE ROOT CAUSES OF THE REPORTED TUBING DISCONNECTION AND THE CRACK WERE NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PRIMARY SET BECAME DISCONNECTED FROM THE Y SITE ON THE NON-BD EXTENSION SET DURING AN INFUSION. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163550 ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2420-0007

    Patients

    Seq Age Sex Outcome Treatment
    1 ICU MEDICAL MC330221, TD (B)(6)