BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR LV5, 12 PK

    MDR report key: 1984233 · Received February 10, 2011

    Report

    Report Number
    6000001-2011-00841
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 21, 2011
    Report Date
    January 24, 2011
    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: RUPTURED CONDITION CONFIRMED. VISUAL EXAMINATION OF THE SAMPLE CONFIRMED A RUPTURED BLADDER IN A FOOTED POSITION. A TIER II (B)(4) WAS INITIATED TO ADDRESS THE ROOT CAUSE INVESTIGATION OF THE BLADDER RUPTURE ISSUE. PER REVIEW OF THE BATCH RECORDS, NO NONCONFORMANCE REPORT WAS DOCUMENTED FOR THIS LOT. ALL RELEASE CRITERIA WERE MET FOR THE BUILD OF THE LOT.

    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 THE RESERVOIR OF ONE (1) INFUSOR LV5 DEVICE HAD RUPTURED DURING PATIENT USE AT THE PATIENT'S HOME. ACCORDING TO THE REPORT, THE DEVICE WAS FILLED WITH 5-FLUOROURACIL AND NORMAL SALINE. THERE IS 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 INFUSOR LV5, 12 PK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10K034

    Patients

    Seq Age Sex Outcome Treatment
    1 5-FLUOROURACIL| NORMAL SALINE