BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3140809 · Received May 31, 2013

    Report

    Report Number
    1416980-2013-13972
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    April 24, 2013
    Report Date
    May 8, 2013
    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: THE SAMPLE WAS RECEIVED BY BAXTER FOR EVALUATION. VISUAL INSPECTION FOUND THAT THE GRADUATION MARKS WERE MISSING FROM THE HOUSING. THE CAUSE WAS DETERMINED TO BE A MACHINE ERROR DURING THE MANUFACTURING PROCESS, WHICH LED TO A FAILURE TO PRINT THE GRADUATION MARKS ON THE HOUSING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED BY BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. THE INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION; HOWEVER THE ROOT CAUSE HAS NOT YET BEEN DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NO GRADUATION MARKS WERE OBSERVED ON THE HOUSING OF AN INFUSOR SV5. THIS WAS OBSERVED AFTER FILLING THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242333 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 12M069

    Patients

    Seq Age Sex Outcome Treatment
    1