BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    MDR report key: 1634438 · Received March 18, 2010

    Report

    Report Number
    6000001-2010-00335
    Event Type
    Malfunction
    Date Received
    March 18, 2010
    Date of Event
    February 12, 2010
    Report Date
    February 19, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). A BAXTER SERVICE TECHNICIAN EVALUATED THE PUMP AND CONFIRMED THE CUSTOMER REPORTED CONDITION OF "FAILED BATTERY" WHICH LED TO AN INTERRUPTION OF THERAPY DUE TO A DEPLETED MAIN BATTERY. THE DEPLETED MAIN BATTERY WAS REPLACED, AND THEN PUMP PASSED ALL FUNCTIONAL TESTS AND WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) REGARDING AN IND FLAG GENERATED FOR ONE PATIENT'S BNP RESULT ON AN ACCESS 2 IMMUNOASSAY ANALYZER. THE CUSTOMER DID NOT REPORT ANY PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED A TECHNICAL SERVICE REPRESENTATIVE TO REPORT A COLLEAGUE INFUSION PUMP THAT BEGAN TO BEEP AND SAID BATTERY FAILED. THIS CONDITION WAS REPORTED AS HAVING OCCURRED DURING PATIENT USE IN THE OB AREA OF THE FACILITY. THE FACILITY REPRESENTATIVE STATED IN A PHONE MESSAGE THAT THE INFUSION WAS INTERRUPTED. THE FACILITY REPRESENTATIVE STATED THAT THERE WERE NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE. UIM MASTER SOFTWARE VERSIONS WITH A SOFTWARE CONFIGURATION NUMBER ENDING IN 6.13.90 WILL BE CATEGORIZED AS REMEDIATED.

    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