BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE ADMINISTRATION SET

    MDR report key: 6380912 · Received March 6, 2017

    Report

    Report Number
    9616066-2017-00298
    Event Type
    Malfunction
    Date Received
    March 6, 2017
    Date of Event
    December 10, 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 PRODUCT(S): CLEAR MICROCLAVE; ICU MEDICAL MC330221; 100ML FRESENUS KABI BAG, NDC 0338-0519-58, LOT 10KE5633, EXP 04/2018, INTRALIPID 20%; THERAPY DATE (B)(6) 2016. CONCLUSION CODE FIELD LEFT BLANK - NO AVAILABLE CODE FOR UNDETERMINED OR UNKNOWN CAUSE. THE CUSTOMER¿S REPORT OF THE TUBING DETACHING FROM THE Y-SITE WAS NOT CONFIRMED, HOWEVER DAMAGE WAS NOTED TO THE SPIN COLLAR. VISUAL INSPECTION SHOWED THAT THE MALE LUER SPIN COLLAR HAD TWO HAIR LINE CRACKS, 0.129 AND 0.193 INCHES LONG. 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 TESTING WAS PERFORMED AND NO DISCONNECTIONS OR LEAKS WERE OBSERVED. PRESSURE TESTING SHOWED NO SIGNS OF LEAKING WHILE THE TUBING WAS MANIPULATED AT EACH ENGAGEMENT. DIMENSIONAL TESTING SHOWED THE MALE LUER TIP WAS WITHIN SPECIFICATIONS. THE ROOT CAUSE OF THE TUBING DISCONNECTING FROM THE Y-SITE WAS NOT IDENTIFIED. THE ROOT CAUSE OF THE CRACK ON THE MALE LUER WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE TUBING BECAME DISCONNECTED FROM THE Y SITE OF A NON-BD SET DURING AN INFUSION OF LIPIDS. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164764 ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2420-0007

    Patients

    Seq Age Sex Outcome Treatment
    1 8100, 8015, THERAPY DATE (B)(6)