BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE IV ADMINISTRATION SET

    MDR report key: 2782155 · Received October 3, 2012

    Report

    Report Number
    9616066-2012-00702
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 11, 2012
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT WILL BE RETURNED PER CUSTOMER AS SET WAS NOT SAVED. THE CUSTOMER COMPLAINT OF SMARTSITE CRACKED AND LEAKING COULD NOT BE CONFIRMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK THAT OCCURRED DURING AN INSULIN INFUSION AND STATED THAT THE PATIENT'S GLUCOSE WAS NOT RESPONDING. THE PATIENT REQUIRED EXTRA FINGER STICK GLUCOSE READINGS AS A RESULT. THE TUBING WAS CHANGED AND THEN THE PATIENT RESPONDED TO THE INSULIN DRIP. THE CUSTOMER SWABS THE TOP OF THE VALVE WITH ALCOHOL AND ALSO USES A JUICING TECHNIQUE FOR CLEANING. ALTHOUGH REQUESTED, NO ADDITIONAL EVENT OR PATIENT INFORMATION PROVIDED BY THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE IV ADMINISTRATION SET FPA CAREFUSION CORP 2426-0500 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN THERAPY DATE:| ALARIS PUMP MODULE AND ALARIS PC UNIT, SNS UNKNOWN