BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INFUSOR SV 2, 12 PACK

    MDR report key: 1932593 · Received December 18, 2010

    Report

    Report Number
    6000001-2010-05997
    Event Type
    Malfunction
    Date Received
    December 18, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 24, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K041738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: THE ACTUAL DEVICE IS NOT AVAILABLE FOR EVALUATION PER THE CUSTOMER. HOWEVER, A PHOTO OF THE DEVICE IS STATED TO BE AVAILABLE BUT HAS NOT YET BEEN RECEIVED BY BAXTER. SHOULD THE DEVICE, THE PHOTO AND/OR ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THIS DEVICE WAS NOT RETURNED TO BAXTER FOR EVALUATION, THEREFORE THE REPORTED CONDITION COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT ONE (1) CE INFUSOR SV 2 DEVICE WAS OBSERVED LEAKING FROM THE FILL PORT DURING FILLING. THERE IS NO PATIENT INVOLVEMENT; THEREFORE, NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INFUSOR SV 2, 12 PACK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10H030

    Patients

    Seq Age Sex Outcome Treatment
    1