BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPD DISCONNECT Y-SET, BULKPACK DISPOSABLE

    MDR report key: 1790474 · Received August 10, 2010

    Report

    Report Number
    1423500-2010-02325
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    July 11, 2010
    Report Date
    July 11, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K961825
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).SAMPLE NOT AVAILABLE AS PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY.

    Description of Event or Problem · 1

    ON (B)(6), 2010 PRODUCT SURVEILLANCE CONTACTED PERITONEAL DIALYSIS (PD) NURSE REGARDING THE LOW DRAIN VOLUME ALARM. THE NURSE STATED THAT THE HOMECHOICE PATIENT WAS IN THE HOSPITAL LAST WEEK DUE TO PERITONITIS. DATE OF PERITONITIS WAS (B)(6) 2010. PATIENT WAS HOSPITALIZED FROM (B)(6) 2010 TO (B)(6) 2010. PATIENT WAS TREATED WITH TWO GRAMS OF INTRAPERITONEAL ANTIBIOTICS. THE PD NURSE STATED THE CAUSE OF PERITONITIS WAS UNKNOWN, THAT IT WAS NOT RELATED TO ANY BAXTER PRODUCTS OR SOLUTIONS. THE PATIENT HAS RECOVERED FROM THE PERITONITIS. THIS IS COMPLAINT FIVE OF FIVE RELATED COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPD DISCONNECT Y-SET, BULKPACK DISPOSABLE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R THERAPY (B)(4) 1.5% LO/CAL 6L/6L DNL (B)(4) 2.5% L