BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 2032108 · Received March 28, 2011

    Report

    Report Number
    6000001-2011-02270
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    October 1, 2010
    Report Date
    October 15, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE WAS NOT SENT TO BAXTER FOR DEVICE EVALUATION OR REPAIR. THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED NOR CAN AN ASSIGNABLE CAUSE BE PROVIDED. A SERVICE HISTORY REVIEW REVEALED THAT THIS DEVICE HAS NOT BEEN PREVIOUSLY SERVICED FOR THE REPORTED CONDITION. SHOULD THIS PUMP BE RECEIVED BY BAXTER FOR EVALUATION, OR IF ANY ADDITIONAL INFORMATION ABOUT THIS EVENT BECOMES AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A BAXTER SALES REP CALLED IN STATING THAT HE KNEW THAT THERE WAS AN INCIDENT INVOLVING A COLLEAGUE INFUSION PUMP IN THE NEONATAL ICU (INTENSIVE CARE UNIT) AT (B)(6) MEDICAL CENTER. THE CUSTOMER STATED THAT THE DEVICE ORIGINALLY CAME DOWN TO BIOMED SERVICE BECAUSE THE NURSE STATED THAT SHE PROGRAMMED AN INFUSION RATE OF 9 ML/HR (MILLILITERS/HOUR) ON CHANNEL A AND AN INFUSION RATE OF .8 ML/HR ON CHANNEL C AND THE TWO INFUSION RATES FLIPPED DURING PATIENT USE. WHEN THE BIOMEDS LOOKED INTO THE EVENT HISTORY ON THIS DEVICE THEY FOUND THAT THE PUMP ACTED CORRECTLY AND THIS WAS A PROGRAMMING ERROR. THE CUSTOMER STATED THAT THEY WILL NOT BE SENDING THIS DEVICE IN SINCE IT WAS A PROGRAMMING ERROR AND NOT AN ERROR WITH THE PUMP. THE EVENT WAS REPORTED TO HAVE OCCURRED DURING PATIENT THERAPY IN THE NEONATAL ICU. ACCORDING TO THE HOSPITAL REPRESENTATIVE, THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS CURRENTLY UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1