BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR SV 2, 12 PACK

    MDR report key: 1883569 · Received October 26, 2010

    Report

    Report Number
    6000001-2010-04537
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    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: THE DEVICE IS AVAILABLE FOR EVALUATION PER THE CUSTOMER; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. SHOULD THE DEVICE AND/OR ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT A NURSE WAS INJURED DURING THE FILLING OF ONE (1) CE INFUSOR SV2 DEVICE. ACCORDING TO THE REPORT, THE NURSE WAS USING AN AMPULE TO FILL THE INFUSOR. DURING FILLING, THE AMPULE BROKE AND GLASS FRAGMENTS STUCK TO THE OVERPOUCH PACKAGING THE INFUSOR IS PACKAGED IN DUE TO STATIC ELECTRICITY. THERE IS NO FURTHER INFORMATION.

    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