BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYFLUX 17L

    MDR report key: 9588177 · Received January 14, 2020

    Report

    Report Number
    9611369-2019-00216
    Event Type
    Malfunction
    Date Received
    January 14, 2020
    Date of Event
    December 11, 2019
    Report Date
    February 14, 2020
    Manufacturer
    BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER
    Product Code
    KDI
    UDI-DI
    07332414086626
    PMA / PMN Number
    K043342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H3, H6 AND H10. THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, TWO PHOTOGRAPHS OF THE SAMPLE WERE PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE PROVIDED PHOTOS SHOWS THE PRODUCT WAS WET. ON ONE PHOTO, A PARTICULATE MATTER IN OR ON THE BLOOD PORT CONNECTION WAS VISIBLE. IT IS NOT VISIBLE IF THE PARTICULATE MATTER WAS INSIDE OR OUT SIDE THE CONNECTOR. THE REPORTED CONDITION WAS VERIFIED. AS THE ACTUAL DEVICE WAS NOT RETURNED, THE CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. 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 · 0

    ADDITIONAL INFORMATION ADDED TO G5: K043342. 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 PRIMING, ONE UNIT OF POLYFLUX 17L APAC, HAD PARTICULATE MATTER INSIDE THE BLOOD HEADER CONNECTOR. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50696 POLYFLUX 17L DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER NA 9-4210-H-01 07332414086626

    Patients

    Seq Age Sex Outcome Treatment
    1