BEUDAMED
    FDA Adverse Event Death Summary report: N

    PALL FLEX TUBE CONNECTOR

    MDR report key: 1751235 · Received April 23, 2010

    Report

    Report Number
    1751235
    Event Type
    Death
    Date Received
    April 23, 2010
    Date of Event
    March 15, 2009
    Report Date
    April 21, 2010
    Manufacturer
    PALL CORPORATION
    Product Code
    BZA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A (B)(6) (B)(6) PATIENT WITH (B)(6), ON ISOLATION, WITH VERY COMPROMISED LUNG FUNCTION IN CRITICAL CONDITION IN CRITICAL CARE UNIT IN AN ISOLATION ROOM. DOORS TO ROOM CLOSED (PER ISOLATION PROTOCOL). PT BECAME DISCONNECTED FROM THE VENTILATOR AT CONNECTION SITE OF PALL BREATHING CIRCUIT FILTER AND THE PALL 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. CONNECTIONS: ENDOTRACHEAL TUBE INSIDE PT MOUTH CONNECTED TO IN-LINE SUCTION, CONNECTED TO PALL FLEX TUBE, CONNECTED TO PALL BREATHING CIRCUIT FILTER, CONNECTED TO "Y" CIRCUIT, CONNECTED TO VENTILATOR TUBINGS, CONNECTED TO FILTERS, CONNECTED TO 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL FLEX TUBE CONNECTOR HME FLEX TUBE BZA PALL CORPORATION UNK UNK
    2 PALL BREATHING CIRCUIT FILTER "CONSERVE 100" HME FILTER CAH PALL CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Death CONTINUOUS RENAL REPLACEMEN TTHERAPY| INTUBATION & MECHANICAL VENTILATION