BEUDAMED
    FDA Adverse Event Death Summary report: N

    CLEARLINK CONTINU-FLO SET

    MDR report key: 513839 · Received February 26, 2004

    Report

    Report Number
    6000001-2004-00296
    Event Type
    Death
    Date Received
    February 26, 2004
    Date of Event
    January 31, 2004
    Report Date
    February 2, 2004
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTED A DEATH OF A PT THAT WAS ADMITTED TO THE EMERGENCY DEPT FOR DYSPNEA. THE PT WAS IN THE ARMS OF THEIR FAMILY MEMBER AND WAS IN A SITTING POSITION AND OCCASIONALLY STANDING WITH THE ASSISTANCE OF THEIR FAMILY MEMBER. THERE WERE TWO HEALTHCARE PROVIDERS IN THE ROOM. THE PT HAD A PERIPHERAL IV IN THE LEFT FOREARM WITH NORMAL SALINE INFUSING VIA A BAXTER FLO-GARD INFUSION PUMP AT AN UNKNOWN FLOW RATE. THE PT WAS RECEIVING 10MG OF ALBUTEROL VIA A NEBULIZER MASK. ONE OF THE HEALTH PROFESSIONALS REPORTEDLY FOUND THE PROXIMAL END OF THE OXYGEN TUBING DISCONNECTED FROM THE MASK AND REATTACHED IT TO THE CLEARLINK PORT (CLOSEST TO THE PT'S IV CATHETER) OF THE PT'S IV LINE. THE OXYGEN WAS FLOWING AT AN UNKNOWN FLOW RATE WHEN IT WAS ATTACHED TO THE CLEARLINK PORT. THE FACILITY REPORTS THE LAST CHARTED OXYGEN FLOW RATE WAS 2L/MIN. THE FACILITY REPORTED THAT THE SECOND HEALTHCARE PROFEESIONAL NOTICED THAT THE TUBING WAS ATTACHED TO THE CLEARLINK PORT "IMMEDIATELY" AND REMOVED IT "WITHIN 30 SECONDS". TEN TO FIFTEEN SECONDS LATER, THE PT WENT FLACCID IN THEIR FAMILY MEMBER'S ARMS. THE PT WAS PLACED FLAT ON THE GURNEY WITH NO SPONTANEOUS RESPIRATIONS. THE FACILITY REPORTED THAT CARDIOPULMONARY RESUSCITATION WAS PERFORMED BUT WAS UNSUCCESSFUL. AN AUTOPSY WAS PERFORMED AND REPORTEDLY THE CAUSE OF DEATH WAS LISTED AS "MASSIVE AIR EMBOLISM" AND THE MANNER AS "ACCIDENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARLINK CONTINU-FLO SET CONTINU-FLO SOLUTION SET FPA BAXTER HEALTHCARE CORP NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 MFR: ALLEGIANCE HEALTHCARE, MCGAW PARK, IL., 2004| NEBULIZER MASK 'MININEB, VMT.INC.', 2004.| OXYGEN FLOW METER, MODEL# 1MFA1001. MFR:| AIRLINE-OXYGEN TUBING, PRODUCT CODE 001301,| PRECISION MEDICAL, 2004.