BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1801767 · Received August 16, 2010

    Report

    Report Number
    1423500-2010-02538
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    April 1, 2010
    Report Date
    July 21, 2010
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS UNKNOWN AND THEREFORE THE 510K ENTRY FIELD IS LEFT BLANK. AS THE PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THE ROOT CAUSE OF THIS INCIDENT WAS UNDETERMINED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A HOMECHOICE PATIENT (HP) WHOSE NURSE REPORTED THAT IN (B)(6) 2010, THE PATIENT DEVELOPED PERITONITIS. A PERITONEAL DIALYSIS (PD) CULTURE WAS PERFORMED BUT RESULTS WERE UNKNOWN. IN (B)(6) 2010, THE PATIENT WAS PLACED ON HEMODIALYSIS. EVENT OUTCOME WAS NOT REPORTED. AT THE TIME OF THIS REPORT THE PATIENT WAS ON HEMODIALYSIS AND NO LONGER A PATIENT AT THE PD CLINIC. THE NURSE HAD NO FURTHER INFORMATION REGARDING THE EVENT OF PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention LOCAL (PD4) AMBUFLEX