BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR LV5, 12 PK

    MDR report key: 1953334 · Received January 7, 2011

    Report

    Report Number
    6000001-2011-00161
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 14, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: THE DEVICE HAS BEEN RECEIVED BY BAXTER FOR EVALUATION; HOWEVER, THE EVALUATION HAS NOT YET BEGUN. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION AND/OR SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE DEVICE WAS RETURNED TO BAXTER FOR EVALUATION. A VISUAL EXAMINATION WAS PERFORMED. DEVICE EVALUATION CONFIRMED THE REPORTED CONDITION OF A LEAK. THE ROOT CAUSE WAS DETERMINED TO BE TUBING PARTIALLY BROKEN OFF AT THE JUNCTION OF THE LUER. THE DEVICE IS A SINGLE USE DEVICE AND WAS DISCARDED. 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) INFUSOR LV5 DEVICE WAS OBSERVED LEAKING BETWEEN THE TUBING AND THE LUER ADAPTOR. THIS WAS OBSERVED DURING FILLING THE DEVICE WITH NORMAL SALINE. NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR LV5, 12 PK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10G066

    Patients

    Seq Age Sex Outcome Treatment
    1 NORMAL SALINE