BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 7026830 · Received November 13, 2017

    Report

    Report Number
    9616066-2017-01521
    Event Type
    Malfunction
    Date Received
    November 13, 2017
    Date of Event
    October 4, 2017
    Report Date
    October 23, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 1000ML B. BRAUN BAG, NDC 0264-7800-09, LOT UMBER J7J787, EXP 01/20, 0.9% NACL; 250 ML B. BRAUN BAG, NDC 0264-7800-20, LOT NUMBER J7J272, EXP 07/19, MAGNESIUM SULFATE, THERAPY DATE: (B)(6) 2017. ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF LEAKING FROM THE PRIMARY SET WAS CONFIRMED. INITIAL VISUAL INSPECTION OF THE SET DID NOT REVEAL ANY DAMAGE OR ABNORMALITIES. MICROSCOPIC EXAMINATION SHOWED A SMALL, JAGGED, VERTICAL TEAR IN THE SILICONE SEGMENT TUBING. FUNCTIONAL TESTING CONFIRMED LEAKING FROM THE SILICONE JUST BELOW THE UPPER FITMENT. THE CAUSE OF THE LEAK WAS A SMALL TEAR IN THE SILICONE SEGMENT. THE ROOT CAUSE OF THE TEAR IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A PRIMARY TUBING LEAK OCCURRED. THE PRIMARY INFUSION WAS SODIUM CHLORIDE (1000 ML, RATE 150 ML/HR). THE SECONDARY BAG OF MAGNESIUM SULFATE (1 GM / 252 ML), RATE 504 ML / HR WAS ALSO INFUSING. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804354 ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 24010-0007T

    Patients

    Seq Age Sex Outcome Treatment
    1