BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    MDR report key: 1897194 · Received November 12, 2010

    Report

    Report Number
    6000001-2010-04816
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    August 28, 2010
    Report Date
    September 1, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Removal / Correction Number
    6000001-12/1/08-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH A BATTERY ISSUE WAS CONFIRMED BY BAXTER PERSONNEL AS A BATTERY DEPLETED 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.

    Additional Manufacturer Narrative · 1

    (B)(4). A SERVICE HISTORY REVIEW REVEALED THAT THIS DEVICE WAS PREVIOUSLY SERVICED FOR THE REPORTED CONDITION. DURING PREVIOUS SERVICE, THE MAIN BATTERY AND SAFETY HARNESS WERE REPLACED. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT A COLLEAGUE INFUSION PUMP EXPERIENCED A BATTERY ISSUE. IT IS UNKNOWN WHEN OR IN WHICH CARE AREA THIS EVENT OCCURRED. DURING REVIEW OF THE PUMP'S EVENT HISTORY, BAXTER PERSONNEL CONFIRMED THE REPORTED CONDITION AS A BATTERY DEPLETED ALARM AND DISCOVERED THIS EVENT INTERRUPTED DELIVERY. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE EVENT IN ASSOCIATION WITH THIS CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 6.13.92.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1