BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE C VOLUMETRIC INFUSION PUMP

    MDR report key: 5551783 · Received October 24, 2007

    Report

    Report Number
    6000001-2007-10240
    Event Type
    Malfunction
    Date Received
    October 24, 2007
    Date of Event
    September 5, 2007
    Report Date
    September 26, 2007
    Manufacturer
    RBAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    PMA / PMN Number
    K010566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: MFR. REPORT # 2954761-2007-00003 ((B)(4)) WAS GENERATED AND MAILED TO THE FDA IN ERROR ON (B)(6) 2007. ALL INFORMATION RESIDING IN MFR. REPORT # 2954761-2007-00003 ((B)(4)) CAN BE FOUND IN THIS MEDWATCH. EVALUATION SUMMARY: THE REPORTED FAILURE CODE 302:435:118:0003 WHICH CAUSED THE UNINTENDED PUMP SHUTDOWN WAS CONFIRMED ONCE IN THE EVENT HISTORY. THE FAILURE CODE OCCURRED ON (B)(6) 2007 AND WAS ATTRIBUTED TO A BROKEN J6 CONNECTOR LOCATED INSIDE THE USER INTERFACE MODULE PRINTED CIRCUIT BOARD (UIM PCB). THE UIM PCB WILL BE REPLACED.

    Description of Event or Problem · 1

    A BAXTER FIELD SERVICE ENGINEER REPORTED AN INFUSION PUMP WITH FAILURE CODE 302:435:118:0003. THE EVENT WAS REPORTED TO HAVE OCCURRED DURING PATIENT INFUSION. ACCORDING TO A TAG FOUND ON THE PUMP THE DEVICE WENT INTO FAILURE (UNINTENDED SHUTDOWN) DURING PATIENT TRANSPORT. THE PUMP WAS NOTED TO HAVE AN ALARM BLARING. ACCORDING TO A HOSPITAL REPRESENTATIVE, NO PATIENT INJURY HAD BEEN REPORTED RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION OR CONTACT WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE C VOLUMETRIC INFUSION PUMP 80FRN FRN RBAXTER HEALTHCARE PTE. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1