BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BICARBY DIALYSATE RFP-401

    MDR report key: 24969976 · Received April 23, 2026

    Report

    Report Number
    MW5187240
    Event Type
    Malfunction
    Date Received
    April 23, 2026
    Date of Event
    April 19, 2026
    Report Date
    April 20, 2026
    Manufacturer
    FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC.
    Product Code
    KPO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DIALYSATE BAGS FOR CRRT (CRRT DIALYSATE RFP-401 INFUSION) BREAK WHEN ATTEMPTING TO HANG NEW BAGS. AT THE CONNECTOR WHERE YOU HAVE TO BREAK THE SEAL, THE WHOLE PIECE FALLS OUT INSTEAD OF JUST BREAKING. FALANGE ON CRRT DIALYSATE BAGS BREAKING OFF COMPLETELY WHEN SPIKING BAGS. LOT 26AG06016 DIALYSATE BAG FOR CRRT CRACKED/BROKE OPEN ON SIDE SEAM OF BAG WHEN RECONSTITUTING/MIXING CHAMBERS RESULTING IN WASTED MEDICATION/SUPPLY D/T CONTAMINATION RISK FROM DEFECTIVE MEDICATION PACKAGING BICARBY DIALYSATE RFP 401 FRESENIUS MEDICAL REF #RFP-401- G LOT #25SG06037 CRRT DIALYSATE BAG LUER CONNECTION CAME APART WHILE CHECKING CRRT SETUP.RFP-401 MANUFACTURER FRESENIUS; REF # RFP-401-G, LOT #25SG06038. PT: 4582. DEVICE: 1069. REF: MW5187241, MW5187242.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035265 BICARBY DIALYSATE RFP-401 DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) KPO FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC. 25SG06038

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown