BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 1230088 · Received November 17, 2008

    Report

    Report Number
    6000001-2007-88747
    Event Type
    Injury
    Date Received
    November 17, 2008
    Date of Event
    June 13, 2007
    Report Date
    June 18, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Removal / Correction Number
    6000001-06/21/07-004-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. THE PUMP IS ENROUTE TO THE BAXTER PAL LAB FOR EVALUATION. A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED CONDITION OF FAIL CODE 16:310:867:0002 WAS CONFIRMED BUT NOT DUPLICATED DURING SERVICE. THE FAIL CODE IS RELATED TO A SOFTWARE BUFFER OVERFLOW. TUBE LOAD/UNLOADS WERE PERFORMED ON EACH PUMP HEAD MODULE CHANNEL, EACH TIME THE SAFETY SLIDE CLAMP ENGAGED AND DISENGAGED WITH NO OBSERVABLE DEFECTS. THE KEYPAD TEST WAS PERFORMED ON ALL KEYS AND THE LOCKOUT BUTTON ARE WORKING CORRECTLY. AN INTERNAL INSPECTION WAS PERFORMED ON THE FRONT BEZEL, THE COMMUNICATION HARNESS WAS INSERTED CORRECTLY AND DOES NOT HAVE ANY DAMAGED, THE KEYPAD FLEX CABLE DOES NOT HAVE ANY CUTS AND HAS THE PRE-INSTALLED INSULATOR PRESENT. THE PUMP HEAD MODULE COMMUNICATION CABLE WAS INSPECTED AND HAS NO SIGNS OF DAMAGED AND WAS CONNECTED CORRECTLY ON ALL THREE PUMP HEAD MODULES.

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT AN UPGRADED LOANER COLLEAGUE PUMP FAILED ON ALL 3 CHANNELS ON A PATIENT IN ICU. THIS WAS A MALE ICU PATIENT, POST OPEN-HEART SURGERY, USING THE COLLEAGUE PUMP WHEN ALL THREE CHANNELS FAILED. THE PATIENT WAS RECEIVING LEVOPHED, EPINEPHRINE AND DOPAMINE (CONCENTRATION, DOSE, RATE AND VOLUME UNKNOWN) AT THE TIME OF THE EVENT. THE PATIENT'S BLOOD PRESSURE HAD BEEN 90-100'S AND DROPPED INTO THE 60-70'S DURING THE EVENT. IT IS UNKNOWN WHAT INTERVENTIONS WERE USED TO RESTORE THE BLOOD PRESSURE. THIS WAS THE 3RD PUMP UTILIZED ON THIS PATIENT ON THE SAME DATE, WHICH FAILED ON ALL THREE CHANNELS.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP 80FRN FRN BAXTER HEALTHCARE PTE. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other| R