BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFURBED COLLEAGUE CX TRIPLE CCHANNEL VOLUMETRIC INFUSION PU

    MDR report key: 1891417 · Received November 4, 2010

    Report

    Report Number
    6000001-2010-04729
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 24, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Removal / Correction Number
    6000001-12/1/08-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH A BATTERY LOW ALARM WAS CONFIRMED DURING PRODUCT EVALUATION BY BAXTER QUALITY ENGINEERING. THIS CONDITION WAS CAUSED BY DAMAGED MAIN BATTERIES. THE MAIN BATTERIES AND BATTERY HARNESS WERE REPLACED TO CORRECT THIS CONDITION. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH MDQ-CAPA-(B)(4). A SERVICE HISTORY REVIEW REVEALED THAT THIS DEVICE WAS PREVIOUSLY SERVICED FOR THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER, THE DEVICE IS AVAILABLE FOR EVALUATION; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD THE DEVICE BE RECEIVED AND EVALUATED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THIS DEVICE IS AN UNREMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.04.00.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WITH A BATTERY LOW ALARM DURING PATIENT THERAPY; INTERRUPTING DELIVERY. IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. ACCORDING TO THE HOSPITAL REPRESENTATIVE, THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION RELATED TO THE DEVICE. THE SOFTWARE VERSION OF THIS DEVICE IS CURRENTLY UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1