BEUDAMED
    FDA Adverse Event Death Summary report: N

    PALL CONSERVE 100 BREATHING CIRCUIT FILTER WITH FLEX TUBE

    MDR report key: 1915975 · Received December 6, 2010

    Report

    Report Number
    9680602-2010-00005
    Event Type
    Death
    Date Received
    December 6, 2010
    Date of Event
    March 15, 2009
    Report Date
    April 15, 2010
    Manufacturer
    PALL NEWQUAY
    Product Code
    CAH
    PMA / PMN Number
    K791307
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    CONTINUOUS RENAL REPLACEMENT THERAPY, INTUBATION AND MECHANICAL VENTILATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) PT WITH (B)(6) IN ISOLATION, WITH VERY COMPROMISED LUNG FUNCTION IN CRITICAL CONDITION IN CRITICAL CARE UNIT IN AN ISOLATION ROOM, WITH THE DOORS TO THE ROOM CLOSED (PER ISOLATION PROTOCOL), AND BECAME DISCONNECTED FROM THE VENTILATOR AT THE CONNECTION SITE OF THE COMPANY'S BREATHING CIRCUIT FILTER AND THE FLEX TUBE. THE NURSE HEARD VENT ALARMS (BUT POSSIBLY NOT FOR 90 SECONDS), AND WENT IN TO CARE FOR PT. ONE TO TWO MINUTES LATER, THE PT CODED AND EXPIRED. REPORTER INDICATED THAT THE MEDWATCH WAS SUBMITTED BECAUSE OF CONCERN ABOUT THE DESIGN OF CONNECTORS IN BREATHING CIRCUIT COMPONENTS. CONNECTIONS: ENDOTRACHEAL TUBE INSIDE THE PT MOUTH, WHICH WAS CONNECTED TO IN-LINE-SUCTION, WHICH WAS CONNECTED TO THE COMPANY'S FLEX TUBE, WHICH WAS CONNECTED TO THE COMPANY'S BREATHING CIRCUIT FILTER, WHICH WAS CONNECTED TO "Y" CIRCUIT, WHICH WAS CONNECTED TO VENTILATOR TUBINGS, WHICH WAS CONNECTED TO FILTERS, WHICH WAS CONNECTED TO THE VENTILATOR. NONE OF THESE CONNECTIONS ARE LOCKED OR SECURED IN ANY WAY BY ANY SORT OF LOCKING OR CLAMPING MECHANISM BY DESIGN, ALLOWING FOR POTENTIAL FOR DISCONNECTIONS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL CONSERVE 100 BREATHING CIRCUIT FILTER WITH FLEX TUBE HEAT AND MOISTURE CONDENSER (ARTIFICIAL NOSE), CAH PALL NEWQUAY BB100F UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Male Death