BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADD-ON BURETTE

    MDR report key: 2090518 · Received April 19, 2011

    Report

    Report Number
    9616066-2011-00132
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    February 3, 2011
    Report Date
    March 1, 2011
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K780130
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: 04/18/2011. (B)(4). THE CUSTOMER'S EXPERIENCE OF LEAKING FROM THE VENT OF THE BURETTE SET AND FROM THE VENT OF THE PRIMARY SET'S DRIP CHAMBER WAS CONFIRMED. THE LEAKING OCCURS BECAUSE THE VENT MEDIA, IN BOTH CASES, HAD BECOME SATURATED WHICH ALLOWED FLUID TO PASS THROUGH. THE ROOT CAUSE OF THIS LEAKING HAS BEEN IDENTIFIED AS A USER ISSUE. WHEN PROPERLY USED, THE VENTS DO NOT COME INTO DIRECT CONTACT WITH FLUID ENOUGH TO ALLOW SATURATION OF THE VENT MEDIA THAT COULD CAUSE WETTING OUT OR LEAKING. THE CUSTOMER WAS PROVIDED INFO THAT IF THE BURETTE IS USED AS A FLOW THROUGH DEVICE, THE VENT ON THE TOP OF THE BURETTE SHOULD BE CLOSED. A TIP SHEET ON PROPER USE OF BURETTES WAS SENT TO THE CUSTOMER.

    Description of Event or Problem · 1

    IN THE ONCOLOGY ICU, CHEMO (ETOPOSIDE) LEAKED FROM THE VENT AT THE TOP OF THE ADD-ON BURETTE. THE BURETTE WAS BEING USED AS A FLOW THROUGH DEVICE WHERE THE ROLLER CLAMP ABOVE THE BURETTE WAS LEFT OPEN AND BOTH VENTS ON THE SET-UP WERE LEFT OPEN. RATE WAS BETWEEN 100-200MLS/HR. UNK HOW LONG AFTER THE INFUSION WAS STARTED THAT THE LEAK OCCURRED. ALSO, REPORTED THAT THERE WAS A LEAK AT THE DRIP CHAMBER VENT OF THE PRIMARY SET. LESS THAN 10ML OF CHEMO LEAKED. NO PT OR USER HARM REPORTED. MINOR DELAY IN CHEMOTHERAPY FOR A TRANSPLANT PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADD-ON BURETTE FPA CAREFUSION CORP. 82113E UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MODEL 10013072| ALARIS EXTENSION SET: MODEL 20350E, LOTS UNK| ALARIS PUMP MODULE ADMINISTRATION SET