BEUDAMED
    FDA Adverse Event Other Summary report: N

    CAREFUSION

    MDR report key: 3316214 · Received August 21, 2013

    Report

    Report Number
    2021710-2013-00059
    Event Type
    Other
    Date Received
    August 21, 2013
    Date of Event
    July 22, 2013
    Report Date
    July 22, 2013
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K032451
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013, CAREFUSION SENT AN EMAIL TO THE USER FACILITY SEEKING ADDITIONAL INFO CONCERNING THE REPORTED EVENT AND THE CONDITION OF THE PT. AS OF (B)(4) 2013 THERE HAS BEEN NO RESPONSE FROM THE USER FACILITY. THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MFR. EVENT CODES WERE DERIVED BASED ON INFO DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION(S) WITH A USER FACILITY REP. (B)(4). THE FOLLOWING INFO CONCERNING THE EVAL OF THE DEVICE IS A SUMMARY OF INFO DOCUMENTED BY THE CAREFUSION FIELD SERVICE REP AND THE CAREFUSION FAILURE ANALYSIS LAB TECH. THE CAREFUSION FIELD SERVICE REP EVALUATED THE DEVICE, VERIFIED THE COMPLAINT AND DETERMINED THAT THE ROOT CAUSE OF THE REPORTED EVENT WAS A FAULTY BLENDER ASSEMBLY. UPON RECEIPT TO THE FACTORY, THE CAREFUSION FAILURE ANALYSIS LAB TECH EVALUATED THE BLENDER AND IDENTIFIED AN INTERMITTENT PRESSURE REGULATOR AS THE ROOT CAUSE IN THE REPORTED EVENT. THE CAREFUSION FIELD SERVICE REP REPLACED THE BLENDER AND RAN THE DEVICE THROUGH A COMPLETE USER VERIFICATION TEST TO ENSURE IT MEETS ALL FACTORY SPECS. UPON COMPLETION THE DEVICE WAS RETURNED TO THE CUSTOMER READY TO BE PLACED BACK INTO SERVICE. CAREFUSION HAS INITIATED AN INTERNAL CORRECTIVE ACTION REQUEST THROUGH OUR CORRECTIVE AND PREVENTATIVE ACTION SYSTEM TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH USER FACILITY REP(S). "WHILE ON A PT THE VENTILATOR ALERTED NEEDS O2 CAL, THE PT BRIEFLY DESATURATED TO 81%. THE PT WAS IMMEDIATELY PLACED ON ANOTHER VENTILATOR WITHOUT INCIDENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406414 CAREFUSION CBK CAREFUSION VELA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ASKU