BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3043451 · Received March 13, 2013

    Report

    Report Number
    9616066-2013-00169
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 25, 2012
    Report Date
    February 26, 2013
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVAL.

    Description of Event or Problem · 1

    REPORT RECEIVED OF AN RN WHO STARTED A SECONDARY INFUSION OF ANCEF 2 GRAMS AND NOTICED AFTER HE UNCLAMPED THE SECONDARY LINE, THE PRIMARY BAG (SALINE) BEGAN TO BUBBLE AND THE PRIMARY BAG DRIP CHAMBER VOLUME AND BAG VOLUME INCREASED. THE DRIP CHAMBER OF THE SECONDARY BAG WAS DRIPPING VERY FAST. HE CLAMPED THE PRIMARY, ALLOWED THE SECONDARY TO INFUSE, THEN UNCLAMPED THE PRIMARY INFUSION AT THE COMPLETION OF THE SECONDARY INFUSION. THE INFUSION WAS STARTED IN OUTPATIENT SURGERY, CONTINUED IN OPERATING ROOM AND RECOVERY ROOM, AND THEN TO "JOINT CAMP", WHERE THE EVENT OCCURRED. CUSTOMER REPORTED THAT THERE WAS NO PT HARM OR MEDICAL INTERVENTION. NO FURTHER PT OR EVENT DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106273 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP. 2420-0500 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN ALARIS SECONDARY ADMIN SET, MODEL/LOT UNKNOWN| ALARIS PUMP MODULE, SN UNKNOWN| ALARIS PC UNIT, SN UNKNOWN