BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INFUSOR,LV 2 ML/H 12 PACK

    MDR report key: 1883374 · Received October 26, 2010

    Report

    Report Number
    6000001-2010-04521
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    August 27, 2010
    Report Date
    September 3, 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. THE DEVICE HAS BEEN RECEIVED BY BAXTER; HOWEVER, THE DEVICE EVALUATION HAS NOT YET BEEN COMPLETED. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: ONE SAMPLE WAS RECEIVED BY BAXTER FOR EVALUATION. THE REPORTED CONDITION OF "BACKFLOW" WAS CONFIRMED DUE TO A SMALL PIECE OF GLASS AMPOULE TRAPPED UNDER THE CHECK-BAND. NO OTHER CAUSE OF BACK-FLOW WAS FOUND DURING THE EXAMINATION OF THE SAMPLE. THE GLASS AMPOULE WAS INTRODUCED INTO THE FLUID PATHWAY AND TRAPPED UNDER THE CHECK-BAND BECAUSE A FILTER WAS NOT USED DURING THE FILL PROCESS. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THIS IS A SINGLE USE DEVICE AND WILL NOT BE REPAIRED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE 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 FROM THE FILL PORT. THEREFORE, THE STERILE FLUID PATHWAY WAS BREACHED. THIS CONDITION WAS DISCOVERED DURING FILLING. 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 08F075

    Patients

    Seq Age Sex Outcome Treatment
    1