BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMAFLEX SETS (M)

    MDR report key: 19298315 · Received May 13, 2024

    Report

    Report Number
    8010182-2024-00222
    Event Type
    Malfunction
    Date Received
    May 13, 2024
    Date of Event
    April 22, 2024
    Report Date
    June 11, 2024
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    UDI-DI
    07332414064556
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION MADE TO G4: PMA/510K # OR BLA #: K041005 (PREVIOUSLY SUBMITTED AS NA). H10: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND THE CONE OF THE RETURN MALE LUER LOCK (MLL) WAS OBSERVED BROKEN. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. A NONCONFORMANCE HAS BEEN OPENED TO ADDRESS THIS ISSUE. 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

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RETURN LINE Y CONNECTOR OF A PRISMAFLEX M100 SET WAS BROKEN AND LEAKING FLUID DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843231 PRISMAFLEX SETS (M) DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION NA 23D0072CA 07332414064556

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown