BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2961011 · Received January 16, 2013

    Report

    Report Number
    9616066-2013-00023
    Event Type
    Malfunction
    Date Received
    January 16, 2013
    Report Date
    December 26, 2012
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER'S REPORTED LEAK AT THE CONNECTION BETWEEN BURETTE AND DRIP CHAMBER. THE COMPLAINT COULD NOT BE CONFIRMED DUE TO THE PRODUCT WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED SET LEAKED AT WHITE CONNECTION BETWEEN BURETTE AND DRIP CHAMBER ON A CHEMO INFUSION. NO PATIENT OR STAFF HARM. THE LOCATION OF THE LEAK ON THE SET WAS NOT PROVIDED. CUSTOMER STATED THAT NO FURTHER PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24992 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP 10012293 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT, SN UNK| ALARIS PUMP MODULE, SN UNK