BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION

    MDR report key: 2840332 · Received November 7, 2012

    Report

    Report Number
    2021710-2012-00100
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    September 4, 2012
    Report Date
    September 4, 2012
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAREFUSION FAILURE ANALYSIS LAB TECH EVALUATED THE RETURNED 3100A FILTERED PATIENT CIRCUIT PN: 11518-850S, LOT #Y09S2493 AND VERIFIED THE REPORTED ISSUE. THE TUBE THAT RUNS FROM THE HUMIDIFIER TO THE MAIN BODY OF THE PATIENT CIRCUIT WAS LOOSE AND DISCONNECTS FROM THE MAIN BODY. THIS IS A KNOWN ISSUE THAT HAS PREVIOUSLY BEEN ADDRESSED VIA INTERNAL CORRECTIVE ACTION. IN APRIL 2011, CAREFUSION RELEASED AN ENGINEERING CHANGE ORDER THAT RESULTED IN A PROCESS IMPROVEMENT TO THIS CONNECTION IN ORDER TO PERMANENTLY BOND THE TUBE TO THE MAIN BODY OF THE PT CIRCUIT. BASED ON THE LOT NUMBER OF THIS FILTERED PT CIRCUIT CAREFUSION HAS DETERMINED IT WAS MANUFACTURED IN DECEMBER 2009, APPROX 17 MONTHS PRIOR TO THE RELEASE OF THE PROCESS CHANGE. CAREFUSION CONDUCTED A RISK ASSESSMENT FOR THESE EVENTS AND THE RISK LEVEL WAS DETERMINED TO BE "AS LOW A REASONABLY PRACTICABLE (ALARP)."

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS COPIED FROM THE USER FACILITY MEDWATCH REPORT RECEIVED BY CAREFUSION FROM THE FDA ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAREFUSION VENTILATOR, HIGH FREQUENCY / LSZ LSZ CAREFUSION FILTERED PATIENT CIRCUIT Y09S2493

    Patients

    Seq Age Sex Outcome Treatment
    1 16 DA Other ASKU