BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 2013774 · Received March 10, 2011

    Report

    Report Number
    6000001-2011-01781
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 7, 2011
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 WAS PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS CUSTOMER SERVICE REQUEST ON THIS PUMP. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH A LOW BATTERY ALARM WAS CONFIRMED BY BAXTER PERSONNEL AS A DEPLETED BATTERY ALARM. THIS CONDITION WAS CAUSED BY DEPLETED MAIN BATTERIES. THIS CONDITION WAS RESOLVED AT THE FACILITY BY A BAXTER FIELD SERVICE TECHNICIAN BY REPLACING THE MAIN BATTERIES AND BATTERY HARNESS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE INFUSION PUMP WITH A LOW BATTERY ALARM. ACCORDING TO THE FACILITY, IT IS UNKNOWN WHEN OR IN WHICH CARE AREA THIS EVENT OCCURRED. UPON REVIEWING THE PUMP'S EVENT HISTORY, BAXTER QUALITY ENGINEERING DISCOVERED THAT A BATTERY DEPLETED ALARM INTERRUPTED DELIVERY. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS DEVICE IS AN UNREMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.04.00.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1