BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2962034 · Received January 23, 2013

    Report

    Report Number
    9616066-2013-00033
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    December 31, 2012
    Report Date
    December 31, 2012
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER'S REPORT THAT SECONDARY MEDICATION DID NOT INFUSE. ALTHOUGH REQUESTED, THE SET HAS NOT BEE RECEIVED FOR EVAL. A FOLLOW UP REPORT WILL BE SUBMITTED WITH EVAL RESULTS SHOULD THE SET BE RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A SECONDARY MEDICATION DID NOT INFUSE. THE NURSE DISCOVERED THIS WHEN IT WAS TIME FOR THE NEXT DOSE. UPON HANGING THE NEXT DOSE, USING THE SAME TUBING, THE NURSE NOTED THE PRIMARY AND SECONDARY INFUSION BAGS WERE DRIPPING AT THE SAME TIME. RATES OF INFUSION FOR BOTH WERE 200 ML/HR. THE PRIMARY INFUSION BAG WAS HANGING LOW AND THE DRIP CHAMBER FOR THE PRIMARY TUBING WAS TOUCHING THE TOP OF THE PCU. THE SECONDARY BAG WAS HANGING HIGHER THAN THE PRIMARY BAG (HEAD HEIGHT DIFFERENCE WAS NOT PROVIDED). ALTHOUGH REQUESTED, NO FURTHER PT OR EVENT DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32670 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP. 2420-0500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LOT NUMBER UNK| ALARIS SECONDARY ADMINISTRATION SET: MODEL 72213N| ALARIS PC UNIT: SN UNK| ALARIS PUMP MODULE: SN UNK