BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3983203 · Received June 27, 2014

    Report

    Report Number
    9616066-2014-00660
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Report Date
    June 17, 2014
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K931173
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: 06/27/2014. (B)(4). UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER'S REPORTED COMPLAINT BECAUSE THE SET HAS BEEN DISCARDED BY THE CUSTOMER AND WILL NOT BE RETURNED. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A TAXOL PRIMARY INFUSION INFUSED INTO THE SHORT SET AND THE 50ML IV FLUID BAG BURST. THE PRIMARY INFUSION RATE WAS 600ML/HOUR AND THE SHORT SET WAS CONNECTED TO THE PORT JUST BELOW THE DEVICE VIA GRAVITY. THE NURSE FELT SHE COMPLETELY CLOSED THE SHORT SET SLIDE CLAMP AND ROLLER CLAMP, BUT THE PRIMARY INFUSED UP THE SHORT SET EVEN THOUGH THE CLAMPS WERE CLOSED. THERE WAS NO PT HARM OR MED INTERVENTION. ALTHOUGH REQUESTED, NO ADDITIONAL PT OR EVENT DETAILS WERE PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377145 ALARIS PUMP MODULE ADMINISTRATION SET IV INFUSION SET FPA CAREFUSION CORP 2204-0007 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PRIMARY TUBING, MFR/MODEL/LOT UNK| ALARIS PCU, SN UNK| PUMP MODULE, SN UNK