BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXSTAGE RFP 401

    MDR report key: 24650122 · Received March 20, 2026

    Report

    Report Number
    MW5185490
    Event Type
    Malfunction
    Date Received
    March 20, 2026
    Date of Event
    February 26, 2026
    Report Date
    March 16, 2026
    Manufacturer
    FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC.
    Product Code
    KPO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WE HAVE RECEIVED 26 REPORTS OF PRODUCT DEFECTS WITH FRESENIUS CRRT NXSTAGE DIALYSATE BAGS FROM 2/26/2026-3/13/2026 (TOTAL OF 29 BAGS IMPACTED). THESE EVENT REPORTS WERE RELATED TO NXSTAGE RFP-401 AND ACROSS SEVERAL LOT NUMBERS. END USERS ARE REPORTING THAT THE BAGS ARE LEAKING AND/OR FLUID IS SPRAYING WHEN CRACKED. THERE ARE SEVERAL REPORTS OF THE LUER LOCK/CONNECTOR FALLING OFF THE BAG AS WELL CAUSING THE FLUID TO FLOW OUT OF THE BAG. I AM REPORTING THIS TO THE FDA FOR THE SECOND TIME - WE CONTINUE TO RECEIVE PRODUCT DEFECT REPORTS AND WANTED TO PROVIDE ADDITIONAL INFORMATION. PT: 4582. DEVICE: 1250, 2292, 2907. REF: MW5185464, MW5185465, MW5185466, MW5185467, MW5185469, MW5185470, MW5185532, MW5185471, MW5185472, MW5185473, MW5185474, MW5185475, MW5185476, MW5185477, MW5185478, MW5185479, MW5185480, MW5185481, MW5185482, MW5185483, MW5185484, MW5185485, MW5185486, MW5185487, MW5185488, MW5185489, MW5185491.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713012 NXSTAGE RFP 401 DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) KPO FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other