BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFURBED COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNE

    MDR report key: 1981079 · Received February 8, 2011

    Report

    Report Number
    6000001-2011-00720
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Removal / Correction Number
    6000001-3/15/05-007-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONDITION OF FAILURE CODE 810:11 WAS CONFIRMED THROUGH THE EVENT HISTORY DUE TO OUT OF CALIBRATION AIR-IN-LINE PRINTED CIRCUIT BOARD. THE AIR-IN-LINE PRINTED CIRCUIT BOARD WAS RECALIBRATED TO CORRECT THE REPORTED CONDITION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THERE IS AN ONGOING CAPA INVESTIGATION, MDQ-CAPA-0224 ASSOCIATED WITH THIS REPORT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE FOLLOWING INFORMATION WAS INADVERTENTLY OMITTED FROM THE PREVIOUS MEDWATCH. THE DEVICE HAS NOT BEEN PREVIOUSLY SENT INTO SERVICE FOR THE REPORTED CONDITION OF FAILURE CODE 810:11. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DURING REVIEW OF THE EVENT HISTORY BY BAXTER SERVICE IT WAS DETERMINED THAT A FAILURE CODE 810:11 OCCURRED DURING DELIVERY CAUSING AN INTERRUPTION OF DELIVERY. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THIS DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE VERSION 5.09.90 CATEGORIZED AS REMEDIATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1