BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 6083396 · Received November 7, 2016

    Report

    Report Number
    9616066-2016-01496
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Date of Event
    October 12, 2016
    Report Date
    October 14, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: BAXTER 500ML EXACTAMIX BAG REF (B)(4), LOT 1153568, EXP 2019-5, THERAPY DATE (B)(6) 2016. THE CUSTOMER¿S REPORT OF A PUMP SEGMENT LEAK WAS CONFIRMED. VISUAL INSPECTION OF THE SET UNDER MAGNIFICATION SHOWED A TEAR IN THE CENTER SECTION OF THE SILICONE SEGMENT TUBING. NO CRUSH MARKS OR TOOL MARKS WERE OBSERVED. FUNCTIONAL AND PRESSURE TESTING CONFIRMED LEAKING FROM THE TEAR. THE CAUSE OF THE LEAK WAS DETERMINED TO BE A TEAR IN THE CENTER SECTION OF THE SILICONE SEGMENT TUBING. THE ORIGIN OF THE TEAR WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED LEAKING FROM THE PUMP SEGMENT WHICH WAS DISCOVERED WHEN RESPONDING TO AN AIL ALARM DURING INFUSIONS OF TPN, INTRALIPIDS, BUMEX AND MILRINONE. THE LINE WAS CLAMPED OFF AND THEN REPLACED WITH A HEPARIN AND NORMAL SALINE INFUSION UNTIL REPLACEMENT IV FLUIDS COULD BE OBTAINED FROM THE PHARMACY. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733972 ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2432-0007

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4), THERAPY DATE (B)(6) 2016