BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFURBED COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNE

    MDR report key: 1840565 · Received September 21, 2010

    Report

    Report Number
    6000001-2010-03416
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    July 28, 2010
    Report Date
    August 2, 2010
    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
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS OR ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). A SERVICE HISTORY REVIEW REVEALED THAT THIS DEVICE HAS NOT BEEN PREVIOUSLY SERVICED FOR THE REPORTED CONDITION. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE WRITER INADVERTENTLY OMITTED THE EVALUATION RESULTS IN THE INITIAL MEDWATCH REPORT. THE REPORTED CONDITION WAS CONFIRMED BUT NOT DUPLICATED. THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED AT THIS TIME. THE DEVICE WILL NOT BE REPAIRED FOR THE REPORTED CONDITION SINCE IT IS A STAY-IN UNIT.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WITH AN 810:11 FAILURE CODE. IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. DURING SERVICE AT BAXTER IT WAS DETERMINED THAT THE EVENT OCCURRED DURING DELIVERY. THERE WAS AN INTERRUPTION DURING DELIVERY. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION FOR THIS DEVICE IS 5.09.90, CATEGORIZED AS REMEDIATED. DURING A REVIEW OF THE EVENT HISTORY, IT WAS DISCOVERED THAT THE REPORTED CONDITION OCCURRED ONCE ON (B)(6) 2010 DURING INFUSION.

    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