BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SE PUMP AMINISTRATION SET

    MDR report key: 1901555 · Received November 10, 2010

    Report

    Report Number
    9616066-2010-00323
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 20, 2010
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K931550
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS SET WAS RECEIVED AND FUNCTIONAL TESTING CONFIRMED THE LEAK IN THE ACCUSLIDE BASE. WHEN INSTALLED IN A TEST PUMP DEVICE, FASTER LEAKING WAS OBSERVED AND AIR WAS NOTED IN THE TUBING BELOW THE ACCUSLIDE. THE DEVICE ALARMED FOR AIR IN LINE IMMEDIATELY AND THE INFUSION COULD NOT BE STARTED. THE REPORT OF A CRACK AND LEAK IN THE ACCUSLIDE WAS CONFIRMED; ROOT CAUSE WAS IDENTIFIED AS ENVIRONMENTAL STRESS CRACKING. THE REPORT OF FAILURE TO ALARM FOR AIR IN LINE COULD NOT BE CONFIRMED OR REPLICATED WITH THE SET IN A TEST DEVICE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ACCUSLIDE ON SET CRACKED LENGTHWISE AND LEAKED DURING A PROPOFOL INFUSION. THE SET ALSO ALLOWED AIR INTO THE LINE. THE NURSE NOTICED IT BEFORE AIR COULD REACH THE PT BUT THE AIR IN LINE DETECTOR ON THE PUMP DID NOT ALARM. THERE WAS NO HARM TO THE PT. THE PUMP WAS NOT SEQUESTERED. NO ADDITIONAL INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SE PUMP AMINISTRATION SET FPA CAREFUSION CORP. 10013182 10036559

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SE INFUSION PUMP: SN UNK