BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 1770630 · Received July 27, 2010

    Report

    Report Number
    1423500-2010-01650
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 28, 2010
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENT DISCARDED SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED.

    Description of Event or Problem · 1

    THE WIFE OF A HOME PATIENT (HP) CONTACTED BAXTER ABOUT ANOTHER ISSUE AND REPORTED THAT THE HP HAD AN UNRELATED EVENT OF PERITONITIS. THE HP GOT PERITONITIS ON (B)(6)2010 AND CONSEQUENTLY HAD THE TRANSFER SET REPLACED ON (B)(6)2010. THE HP AT THE TIME WAS STILL ON ANTIBIOTICS. THE HP WENT IN TO THE CLINIC THE WEEK PRIOR AND HAD CLEAR FLUID. THE HP HAS BEEN DOING FINE AND CONTINUING THERAPY ON THE CYCLER AS USUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI-CAP, DISCONNECT W/PVP-1SOLUTION DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention