BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3994130 · Received August 8, 2014

    Report

    Report Number
    1416980-2014-25722
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 15, 2014
    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). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS RECEIVED FOR EVALUATION. DURING VISUAL INSPECTION A KINK WAS OBSERVED BELOW THE DRIP CHAMBER. FURTHER VISUAL INSPECTION REVEALED THAT THE KINK WAS BONDED WITH EXCESSIVE SOLVENT. AIR PASSAGE TESTING WAS COMPLETED AND THE TUBING WAS FOUND TO BE BLOCKED AT THE KINK. THE CAUSE OF THE CONDITION WAS DETERMINED TO BE DUE TO A MANUFACTURING ISSUE. A CAPA HAS BEEN OPENED FOR THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TUBING OF A FLOGARD SOLUTION SET WAS SEALED AT THE BOTTOM OF THE DRIP CHAMBER. THE SEALED TUBING RESULTED IN NO OR A SMALL FLOW OF SOLUTION THROUGH THE DEVICE. THIS WAS FOUND WHILE TRYING TO PRIME THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472297 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 12F30V815

    Patients

    Seq Age Sex Outcome Treatment
    1