BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE ADMINISTRATION SET

    MDR report key: 6247628 · Received January 12, 2017

    Report

    Report Number
    9616066-2017-00036
    Event Type
    Malfunction
    Date Received
    January 12, 2017
    Date of Event
    September 15, 2016
    Report Date
    December 20, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF A BULGE/BALLOON IN THE SILICONE SEGMENT WAS CONFIRMED. A BULGING SILICONE SEGMENT WAS FOUND DURING VISUAL INSPECTION ADJACENT TO THE UPPER FITMENT. TACTILE EXAMINATION FOUND THAT THE SILICONE SEGMENT HAD BEEN WEAKENED. FUNCTIONAL TESTING WAS PERFORMED; NO ALARMS OR BULGE/BALLOONING WAS OBSERVED. THE ROOT CAUSE OF THE SILICONE SEGMENT BULGE WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 1000 ML B.BRAUN BAG NDC 0264-7800-09, LOT J55771, EXP 06/18, 0.9% 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 INFUSING NS 1L THE PUMP ALARMED AND WHEN CHECKED THE IV TUBING WAS FOUND TO HAVE A BULGE IN THE SILICONE SEGMENT BELOW THE UPPER FITMENT. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28805 ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2426-0007

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR 8100,8015, THERAPY DATE UNK