BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOW RECIRCULATION VOLUME APDSET W/CASSETTE

    MDR report key: 1823495 · Received September 2, 2010

    Report

    Report Number
    1423500-2010-03103
    Event Type
    Injury
    Date Received
    September 2, 2010
    Date of Event
    July 11, 2010
    Report Date
    August 10, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER H10C05076 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    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.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE WAS UNABLE TO ADJUST PACER RATE. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM THE USA REGARDING PERITONITIS IN A (B)(6) HOMECHOICE PERITONEAL DIALYSIS (PD) FEMALE PATIENT. 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. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON AN UNREPORTED DATE IN (B)(6) 2010, A PERITONEAL EFFLUENT CULTURE WAS PERFORMED WHICH WAS POSITIVE FOR CHRYSEOBACTERIUM MENINGOSEPTICUM. TREATMENT INFORMATION WAS NOT PROVIDED FOR THE EVENT. ON AN UNREPORTED DATE IN 2010, PD THERAPY WAS WITHDRAWN AND THE PATIENT WAS PLACED ON HEMODIALYSIS. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON AN UNREPORTED DATE IN 2010, THE PATIENT RECOVERED FROM THE PERITONITIS. THE NURSE WAS UNAWARE OF THE CAUSE OF THE PERITONITIS AND STATED "THIS PARTICULAR ORGANISM WAS CAUSED BY WATER." MEDICAL HISTORY INCLUDED END STAGE RENAL DISEASE (ESRD) AND "SOME TYPE OF CYSTIC DISEASE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOW RECIRCULATION VOLUME APDSET W/CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| R