BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFILTER HECHINGEN

    MDR report key: 18576691 · Received January 24, 2024

    Report

    Report Number
    9611369-2024-00007
    Event Type
    Malfunction
    Date Received
    January 24, 2024
    Date of Event
    December 26, 2023
    Report Date
    February 22, 2024
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FIP
    UDI-DI
    07332414114046
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION MADE TO B5: THERE WAS NO PATIENT INVOLVEMENT (PREVIOUSLY SUBMITTED AS THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT). CORRECTION MADE TO D1: BRAND NAME: ULTRAFILTER HECHINGEN (PREVIOUSLY SUBMITTED AS U9000 ULTRAFILTER). CORRECTION TO D2A: COMMON DEVICE NAME: SUBSYSTEM, WATER PURIFICATION (PREVIOUSLY SUBMITTED AS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM). CORRECTION MADE TO D2B: CLASSIFICATION CODE: FIP (PREVIOUSLY SUBMITTED AS KDI). H10: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 NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER FACILITY NAME: . SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN EXTERNAL FLUID LEAK FROM A U9000. THE LEAK WAS OBSERVED WHILE PRIMING THE SET PRIOR TO PATIENT USE. THERE WAS NO REPORT OF 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
    2406539 ULTRAFILTER HECHINGEN SUBSYSTEM, WATER PURIFICATION FIP BAXTER HEALTHCARE CORPORATION NA 2-1806-H-03 07332414114046
    64775 ULTRAFILTER HECHINGEN SUBSYSTEM, WATER PURIFICATION FIP BAXTER HEALTHCARE CORPORATION NA 2-1806-H-03 07332414114046

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown