BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3093510 · Received May 6, 2013

    Report

    Report Number
    1416980-2013-11375
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    March 1, 2013
    Report Date
    April 12, 2013
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT IS NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510(K) NUMBER. A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE. THIS EVENT IS THE SAME AS (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE DEVICE FOR EVALUATION. VISUAL EXAMINATION CONFIRMED THERE WAS A DOUBLE LOOP OF TUBING IN THE ROLLER CLAMP. THE CAUSE WAS DETERMINED TO BE INCORRECT ASSEMBLY BY AN AUTOMATED MACHINE DURING MANUFACTURING. THE MANUFACTURING FACILITY IMPLEMENTED CORRECTIVE ACTIONS TO INCREASE MONITORING OF THE ASSEMBLY PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLO-GARD IV SOLUTION ADMINISTRATION SET HAD "DOUBLE" TUBING IN THE ROLLER CLAMP. THIS ISSUE WAS DISCOVERED BEFORE DEVICE USE. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 3 OF THE SAME REPORTED EVENT FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197482 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA

    Patients

    Seq Age Sex Outcome Treatment
    1