BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSOR PUMP-SINGLE CHANNEL

    MDR report key: 1802006 · Received August 16, 2010

    Report

    Report Number
    6000001-2010-02601
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 24, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON FURTHER INVESTIGATION BY BAXTER, THIS EVENT HAS BEEN DETERMINED TO BE NON-REPORTABLE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE CONDITION OF BATTERY WAS CONFIRMED, BUT WAS NOT DUPLICATED. A DEPLETED BATTERY ALARM WAS FOUND IN THE EVENT HISTORY. THE REPORTED CONDITION IS DUE TO FAULTY MAIN BATTERIES. THE MAIN BATTERIES WERE REPLACED TO CORRECT THE REPORTED CONDITION. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A READINGS ISSUE ON THEIR ADC METER WHILE USING AN AFFECTED TEST STRIP LOT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WITH THE REPORTED CONDITION OF "BATTERY". THIS PROBLEM WAS IDENTIFIED DURING BIO-MED TESTING. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE. DURING BAXTER QUALITY ENGINEERING REVIEW OF THE DEVICE EVENT HISTORY ON JULY 28, 2010, IT WAS DETERMINED THAT A DEPLETED BATTERY ALARM OCCURRED DURING DELIVERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1