BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REF COLLEAGUE CXE SINGLE VOLINFUSTION PUMP W/GUARD FEATURE

    MDR report key: 1821910 · Received August 31, 2010

    Report

    Report Number
    6000001-2010-02908
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 11, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Removal / Correction Number
    6000001-3/15/05-007-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE ROOT CAUSE FOR THIS ISSUE IS CURRENTLY BEING INVESTIGATED THROUGH CAPA (CORRECTIVE AND PREVENTIVE ACTION) INVESTIGATION MDQ-CAPA-(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE ASSIGNABLE CAUSE WAS THE PHM (PUMPHEAD MODULE). THE DEVICE HAS NOT BEEN REPAIRED AT THIS TIME SINCE IT IS A BAXTER OWNED UNIT.

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS OR ADDITIONAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    DURING SERVICE AT BAXTER, IT WAS DISCOVERED A COLLEAGUE INFUSION PUMP THAT HAS A CONSTANT AIR INLINE ALARM WHEN RUNNING THE FUNCTIONAL TEST THE REPORTED CONDITION WAS IDENTIFIED DURING SERVICE. AN INTERRUPTION DURING DELIVERY OCCURRED. THERE WAS NO DOCUMENTED PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION FOR THIS DEVICE IS 6.13.90, CATEGORIZED AS REMEDIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REF COLLEAGUE CXE SINGLE VOLINFUSTION PUMP W/GUARD FEATURE PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1