BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INFUSOR,LV 2 ML/H 12 PACK

    MDR report key: 1840539 · Received September 21, 2010

    Report

    Report Number
    6000001-2010-03413
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    September 6, 2010
    Report Date
    September 10, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. PER THE CUSTOMER, THE DEVICE IS AVAILABLE FOR EVALUATION; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF AN INFUSOR LV 2 DEVICE WHICH WAS LEAKING FROM THE FILL PORT WAS NOT CONFIRMED DURING PRODUCT EVALUATION. INSTEAD, THE DEVICE WAS FOUND TO BE LEAKING AT THE JUNCTION OF THE TUBING AND STRESS MEMBER. THIS CONDITION WAS CAUSED BY INSUFFICIENT BONDING AT THE JUNCTION OF THE TUBING AND STRESS MEMBER. THIS IS A SINGLE USE DEVICE AND WILL BE DISCARDED. A BATCH REVIEW WAS PERFORMED FINDING THAT NO EXCEPTION/NON-CONFORMANCE REPORTS WERE DOCUMENTED FOR THIS LOT. ALL RELEASE CRITERIA WERE MET FOR THE BUILD OF THE LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT AN INFUSOR LV 2 DEVICE WAS FOUND TO BE LEAKING AT THE FILL PORT. THEREFORE, THE STERILE FLUID PATHWAY WAS BREACHED. THIS CONDITION WAS DISCOVERED AS THE DEVICE WAS BEING FILLED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY AS THIS EVENT DID NOT OCCUR DURING PATIENT USE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INFUSOR,LV 2 ML/H 12 PACK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10B044

    Patients

    Seq Age Sex Outcome Treatment
    1