BEUDAMED
    FDA Adverse Event Death Summary report: N

    CLEARLINK SYSTEM EXTENSION SETW/CONTROL-A-FLO REGULATOR

    MDR report key: 1221045 · Received November 4, 2008

    Report

    Report Number
    6000001-2008-00701
    Event Type
    Death
    Date Received
    November 4, 2008
    Date of Event
    October 16, 2008
    Report Date
    October 16, 2008
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FPA
    PMA / PMN Number
    K003225
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED SAMPLE OF A CONTINU FLO, LOT UNKNOWN AND 1 USED SAMPLE OF THE EXTENSION SET, LOT UNKNOWN, WERE REC'D. BOTH SAMPLES ARRIVED HOOKED IN SERIES AND ATTACHED TOGETHER AT THE MALE AND FEMALE LUERS OF THE CONTINU FLO AND EXTENSION SET. ALL CLAMPS WERE IN THE FULLY OPENED POSITION WITH THE EXCEPTION OF THE ROLLER/REGULATING CLAMP OF THE SOLUTION SET. THE CLAMP HAD THE ROLLER AT APPROXIMATELY A 50% CLOSED POTION. THE EXTENSION SET CONTROL-A-FLO REGULATOR WAS RETURNED WITH A DIALED SETTING BETWEEN 75 AND 100 MLS PER HOUR. TEST ONE - AS RETURNED: THE COTNINUE FLO SET WAS SPIKE INTO A 1000 ML 0.9% SODIUM CHLORIDE SOLUTION BAG. BOTH SETS PRIMED NORMALLY IN LINE. THE REGULATING CLAMP WAS FULLY OPENED FOR THIS FUNCTION. A 21-GAUGE NEEDLE WAS THEN ATTACHED TO THE FLO CONTROL LUER. THE REGULATING CLAMP WAS THEN SET BACK TO THE APPROX 50% SHUT OFF POTION. A DRIP RATE OF APPROXIMATELY 3 DROPS PER MINUTE WAS OBSERVED. THE SOLUTION OUT PUT VOLUME WAS THEN COLLECTED IN A 100 ML GLASS GRADUATED CYLINDER FOR A PERIOD OF 60 MINUTES. THE FLUID COLLECTION FOR THE 60 MINUTES WAS APPROXIMATELY 27 MLS. TEST TWO: THE SAME PROCEDURE WAS FOLLOWED AS IN TEST ONE WITH THE EXCEPTION OF THE ROLLER/REGULATING CLAMP BEING PLACED IN THE FULL OPEN POTION. THIS PRODUCED A DRIP RATE OF APPROXIMATELY 14 DROPS PER MINUTE. THE SOLUTION OUT PUT VOLUME WAS AGAIN COLLECTED IN A 100 ML GLASS GRADUATED CYLINDER FOR A PERIOD OF 60 MINUTES. THE FLUID COLLECTION FOR THE 60 MINUTES WAS APPROXIMATELY 88 MLS. THE SETS AND COMPONENTS PERFORMED AS DESIGNED AND THE SOLUTION FLOW OUT PUT COLLECTED IN TEST TWO WAS THAT OF THE SELECTED RATE OF THE RETURNED CONTROL-A-FLO REGULATOR, THE COMPLAINT WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT THE PT WAS INFUSING 0.9% SODIUM CHLORIDE INJECTION (1000ML) VIA A CONTINU-FLO SOLUTION SET AND EXTENSION SET FOR HYDRATION. THE PATIENT'S FAMILY FELT THE SOLUTION WAS NOT GOING FAST ENOUGH AND WAS TOO SLOW AND TOO THICK. THE FAMILY OF THE PT STATED THAT THERE WAS SOMETHING WRONG WITH THE UNIT. THE FAMILY ADVISED THE NURSE TO DISCONTINUE TREATMENT, AND TO SEND THE PRODUCTS FOR EVAL. ON 10/20/08, THE BAXTER SALES REPRESENTATIVE WAS NOTIFIED THAT THE PT EXPIRED (UNKNOWN CAUSE OF DEATH AND UNKNOWN DATE OF DEATH). THE PT HAD DEMENTIA AND HAD BEEN PLACED ON A NG TUBE (NASOGASTRIC TUBE. THE REPORTED UNIT WAS STORED AT ROOM TEMPERATURE AND WAS NOT EXPOSED TO EXTREME TEMPERATURES AT ANY TIME. THE CONTINU-FLO SOLUTION SET WAS SPIKED INTO THE BAG AND WAS FULLY PRIMED. THE CLEARLINK EXTENSION SET WAS ALSO FULLY PRIMED. THE AMOUNT OF SOLUTION REMAINING IN THE BAG IS APPROXIMATELY 100ML. THE SOLUTION, CONTINU-FLO SET AND EXTENSION SET HAVE BEEN RETURNED TO BAXTER FAILURE ANALYSIS LAB (FAL) FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARLINK SYSTEM EXTENSION SETW/CONTROL-A-FLO REGULATOR 80FPA FPA BAXTER HEALTHCARE CORP. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Death