BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2110860 · Received June 2, 2011

    Report

    Report Number
    6000001-2011-06963
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 17, 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). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. THE REPORTED CONDITION OF A LEAK WAS CONFIRMED. UPON SAMPLE RECEIPT, THE DEVICE CONTAINED FLUID IN THE BLADDER. TO VERIFY THE REPORTED CONDITION, THE FILL-PORT CAP WAS REMOVED. UPON REMOVAL, A BACK-FLOW (LEAK) WAS OBSERVED AT THE FILL-PORT. VISUAL EXAMINATION OF THE DISASSEMBLED UNIT REVEALED THE ROOT CAUSE OF THE LEAK WAS A TINY (APPROXIMATELY 0.2 MM IN SIZE) GLASS FRAGMENT UNDER THE CHECK BAND. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT. 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). 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

    BAXTER (B)(4) RECEIVED A REPORT THAT ONE (1) INFUSOR SV 2.5 DEVICE BACKFLOWED DURING FILLING FROM THE FILLING PORT. THE DEVICE WAS BEING FILLED WITH 5-FU AND SALINE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. THERE WAS NO PATIENT INVOLVEMENT. THE ACTUAL SAMPLE IS AVAILABLE. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10H002

    Patients

    Seq Age Sex Outcome Treatment
    1 SALINE| 5-FLUOROURACIL