BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTLET PORT CLAMP

    MDR report key: 10080442 · Received May 21, 2020

    Report

    Report Number
    1416980-2020-02863
    Event Type
    Malfunction
    Date Received
    May 21, 2020
    Date of Event
    April 26, 2020
    Report Date
    June 16, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKK
    UDI-DI
    05413760096186
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IN D10, H3, H6. H10: TWO (2) ACTUAL SAMPLES WERE RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. FUNCTIONAL TESTING WAS PERFORMED WITH NO ISSUES NOTED. THE REPORTED CONDITION WAS NOT VERIFIED. THE REMAINING TWO (2) DEVICES WERE NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF 4 OUTLET PORT CLAMPS FLUID FLOW WAS OBSERVED WITH THE CLAMPS CLOSED. THIS OCCURRED DURING USE OF THE DEVICES FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542247 OUTLET PORT CLAMP CLAMP, LINE FKK BAXTER HEALTHCARE CORPORATION NA 19C28H80 05413760096186

    Patients

    Seq Age Sex Outcome Treatment
    1