BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR SV 2, 12 PACK

    MDR report key: 2030108 · Received March 27, 2011

    Report

    Report Number
    6000001-2011-02233
    Event Type
    Malfunction
    Date Received
    March 27, 2011
    Date of Event
    September 28, 2010
    Report Date
    September 29, 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: PER THE CUSTOMER, THE SAMPLE WILL NOT BE RETURNED TO BAXTER FOR EVALUATION. THEREFORE, THE REPORTED CONDITION COULD NOT BE CONFIRMED. SHOULD THE SAMPLE AND/OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT THE "FLOW WRAP POUCH" OF ONE (1) INFUSOR SV2 DEVICE PRODUCED ENOUGH STATIC ELECTRICITY TO ALLOW FRAGMENTS/PIECES OF THE GLASS AMPULE USED DURING THE FILLING OF THE DEVICE TO ADHERE TO THE POUCH. DURING FILLING OF THE DEVICE, THE NURSE OBTAINED AN UNKNOWN INJURY DUE TO THE ADHERED GLASS FRAGMENTS. THERE IS NO ADDITIONAL INFORMATION. THIS IS REPORT 1 OF 2 WITH THE SAME REPORTED PROBLEM FROM THIS FACILITY FROM PATIENT (B)(6) - NURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR SV 2, 12 PACK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10E023

    Patients

    Seq Age Sex Outcome Treatment
    1 GLASS AMPULE