BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASAL/BOLUS INFUSOR 2 X 2 (15MIN LOCKOUT)

    MDR report key: 1802015 · Received August 16, 2010

    Report

    Report Number
    6000001-2010-02603
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    June 28, 2010
    Report Date
    July 23, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K884505
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER, THE DEVICE IS AVAILABLE FOR EVALUATION; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD THE DEVICE BE RECEIVED AND EVALUATED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE DEVICE WAS RECEIVED BY BAXTER FOR EVALUATION. A VISUAL EVALUATION WAS PERFORMED AND CONFIRMED THE REPORTED CONDITION OF A RESERVOIR RUPTURE. THIS DEVICE IS A SINGLE USE DEVICE AND WILL BE DISCARDED. THE ROOT CAUSE IS CURRENTLY BEING INVESTIGATED UNDER CAPA (B)(4). BATCH REVIEW DETERMINED THAT NO NONCONFORMANCE REPORTS WERE DOCUMENTED FOR THIS LOT DURING MANUFACTURING. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER FOUND THE SCAN AND CONTROL ROOM FILLED WITH SMOKE. THE SMOKE ALARMS WENT OFF AND THE FIRE DEPARTMENT WERE ALERTED AND CAME ONSITE. NO PT WAS INVOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT THE RESERVOIR OF A BASAL/BOLUS INFUSOR RUPTURED DURING PRIMING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BASAL/BOLUS INFUSOR 2 X 2 (15MIN LOCKOUT) PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 10B081

    Patients

    Seq Age Sex Outcome Treatment
    1