BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CXD II

    MDR report key: 1790550 · Received August 10, 2010

    Report

    Report Number
    1423500-2010-02329
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    July 6, 2010
    Report Date
    July 19, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K895673
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ROOT CAUSE COULD NOT BE DETERMINED. THE CURRENT LABELING WAS FOUND TO BE SUFFICIENT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE NOT AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER ALLEGEDLY RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT ROCHE METERS, WITHIN 10 MINUTES: 160 MG/DL (AVIVA) AND 325 MG/DL (ADVANTAGE) CUSTOMER STATES THAT HE WAS NOT FEELING WELL AT THE TIME OF THE READINGS. CUSTOMER TOOK APPROXIMATELY 10-11 UNITS OF HUMALOG BASED UPON THE READINGS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM THE USA OF PERITONITIS IN A (B)(6) FEMALE PATIENT COINCIDENT WITH HOMECHOICE PERITONEAL DIALYSIS THERAPY. ON (B)(6) 2010, DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE REPORTING NURSE STATED THAT ON (B)(6) 2010, THE PATIENT DEVELOPED PERITONITIS AND WAS HOSPITALIZED THE SAME DAY. IT WAS UNKNOWN WHETHER A PERITONEAL EFFLUENT CULTURE WAS PERFORMED. TREATMENT INFORMATION WAS NOT PROVIDED. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED; HOWEVER WHEN THE NURSE WAS ASKED WHAT THE CAUSE OF THE PERITONITIS WAS DUE TO, THE NURSE REPLIED THAT THE PATIENT WAS BEING CARED FOR BY A NURSING HOME STAFF. IT WAS UNKNOWN WHETHER THE PERITONITIS RESOLVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CXD II SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R 1.5% LO/CAL UB 2.5L/3L DIANEAL, 1.5% LO/CAL 6L DIA