BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVACLEAR

    MDR report key: 18989113 · Received March 27, 2024

    Report

    Report Number
    3006552611-2024-00008
    Event Type
    Malfunction
    Date Received
    March 27, 2024
    Report Date
    June 7, 2024
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    PMA / PMN Number
    K130039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION MADE TO D2A: COMMON DEVICE NAME: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM(PREVIOUSLY SUBMITTED AS DIALYZER, CAPILLARY, HOLLOW FIBER) CORRECTION MADE TO D2B: CLASSIFICATION CODE: KDI (FJI) ADDITIONAL INFORMATION: D9, H6 AND H11. H11: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND SHOWED VISIBLE DAMAGE (CRACK) TO THE DIALYSATE CONNECTOR. SEVERAL STRESS MARKS ON THE SIDE OF THE DIALYSIS CONNECTOR WAS OBSERVED. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION 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

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM THE "CONNECTOR COUPLING" OF A REVACLEAR 400 DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1150105 REVACLEAR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION NA C422219701
    2130110 REVACLEAR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION NA C422219701

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown