BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2243562 · Received September 12, 2011

    Report

    Report Number
    1423500-2011-12078
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 19, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER (H11E13033 AND H11F01010) WITH NO DEFECTS NOTED. THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. THE LOT NUMBER IS UNKNOWN THEREFORE NO BATCH REVIEW WAS PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING FOLLOW-UP REGARDING AN UNRELATED ALARM, THE CAREGIVER STATED THE HOME PATIENT WAS CURRENTLY IN THE HOSPITAL WITH PERITONITIS. DURING A FOLLOW UP CALL ON (B)(6) 2011, THE FACILITY NURSE INDICATED: THE EVENT OF PERITONITIS IN (B)(6) 2011 WAS CONFIRMED. THE PATIENT WAS PLACED ON ANCEF 2GM INTRAPERITONEAL (IP) DAILY AND FORTAZ 1GM IP DAILY. THE PATIENT WAS NOT HOSPITALIZED AT THAT TIME. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT ON (B)(6) 2011 DUE TO COMPLAINT OF WEAKNESS AND LOW BLOOD PRESSURE. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2011 AND DISCHARGED ON (B)(6) 2011. IT IS UNKNOWN WHAT TESTS AND INTERVENTIONS WERE PERFORMED. DURING THIS TIME THE PATIENT WAS BEING TREATED FOR THE PERITONITIS. THE PATIENT WAS READMITTED ON (B)(6) 2011 DUE TO COMPLAINTS OF FEVER. THE PATIENT CURRENTLY REMAINS HOSPITALIZED. THE PERITONEAL DIALYSIS CATHETER WAS REMOVED ON (B)(6) 2011. THE PATIENT HAS BEEN TRANSFERRED TO HEMODIALYSIS AT THIS TIME. THE NURSE REPORTED THE BAXTER PRODUCTS AND SOLUTIONS WERE NOT CAUSALLY RELATED TO THE EVENT OF PERITONITIS. THE WIFE IS THE CAREGIVER AND PROVIDES METICULOUS ASEPTIC TECHNIQUE. RETRAINING WAS NOT NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R DIANEAL LOW CAL, SINGLE BAG DEXTROSE 1.50%...| DIANEAL LOW CAL, ULTRA BAG DEXTROSE 4.250%...| DIANEAL LOW CAL, ULTRA BAG DEXTROSE 2.50%...| DIANEAL LOW CAL, SINGLE BAG DEXTROSE 4.250%...| DIANEAL LOW CAL, SINGLE BAG DEXTROSE 2.50%...| DIANEAL LOW CAL, ULTRA BAG DEXTROSE 1.50%...| HOMECHOICE