BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION

    MDR report key: 2071715 · Received April 14, 2011

    Report

    Report Number
    2021710-2011-00028
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 10, 2011
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K073069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING DESCRIPTION OF THE DEVICE EVAL BY THE USER FACILITY WAS COPIED FROM THE USER FACILITY MEDWATCH REPORT RECEIVED FROM THE FDA ON (B)(6) 2011. "BIOMED EVAL ON (B)(6) 2011: VENT #1 (SN # (B)(4)) RECEIVED AFTER BEING INVOLVED IN PT INCIDENT. REPORTED PT WAS ON THE VENTILATOR FOR SEVERAL DAYS WITH NO CONCERNS. MORNING OF (B)(6), THE PT'S EXPIRATORY TIDAL VOLUME (VTE) STARTED TO DECREASE TO WHERE IT WAS HALF OF WHAT WAS ORIGINALLY BEING. PT WAS SUCTIONED AND THEN BRONCHED. IT WAS ORIGINALLY FELT THAT MUCUS PLUGGING WAS THE CONCERN BUT ONCE THE PT WAS RETURNED TO THE VENTILATOR AFTER THE BRONCH PROCEDURE THE VTE WAS STILL LOWER THAN BEFORE. VENTILATOR WAS ELECTIVELY CHANGED OUT AND THE PT WAS PLACED ON A PB 840 VENT. VTE RETURNED TO WHERE THEY WERE PREVIOUSLY (-450 CC). THE AVEA WAS RECEIVED WITH PT CIRCUIT INTACT. THE VENT/CIRCUIT WERE CLEANED AND THE VENT WAS BROUGHT IN FOR TESTING. UNABLE TO DUPLICATE THE ABOVE CONCERN USING THE SAME PT SETTINGS AND CIRCUIT. USING A HAMILTON G5 VENTILATOR AND SAME PT SETTINGS RESULTED IN COMPARATIVE RETURN VTE (-500+). BASED ON THIS IT IS ASSUMED PT ASYNCHRONY, MUCUS PLUGGING, OR OTHER MAY HAVE CONTRIBUTED TO A REDUCED VTE SEEN AT THE BEDSIDE AND NOT VENTILATOR RELATED. USER LOGS ARE NOT ACCESSIBLE AND THERE ARE NOT SERVICE LOGS TO DOWNLOAD. THE DEVICE IS A CAREFUSION SALES DEMO AND ARRANGEMENTS HAVE BEEN MADE WITH THE CAREFUSION SALES REP TO HAVE A CAREFUSION FIELD SERVICE REP EVALUATE THE DEVICE. ONCE THE EVAL IS COMPLETE, CAREFUSION WILL SUBMIT A F/U MEDWATCH REPORT. A REVIEW OF THE CAREFUSION COMPLAINT SYSTEM FOR THE PAST 90 DAYS DID NOT FIND ANY VERIFIED LIKE FAILURES, THUS AT PRESENT CAREFUSION CONSIDERS THIS TO BE AN ISOLATED INCIDENT.

    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) 2011. "WHAT WAS THE ORIGINAL INTENDED PROCEDURE? PT WITH PMH SIGNIFICANT FOR HTN, OBESITY, OSA, TRANSFERRED FROM (B)(6) CONCERNING FOR HYPOXIC RESPIRATORY FAILURE AND ARDS OF UNK ORIGIN." "DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAREFUSION VENTILATOR, CONTINUOUS, FACILITY USE/CBK CBK CAREFUSION AVEA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other ASKU