BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2842579 · Received November 21, 2012

    Report

    Report Number
    1416980-2012-05741
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    October 1, 2012
    Report Date
    November 2, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(4) 2012, PRODUCT SURVEILLANCE CONTACTED THE NURSE REGARDING THE REPORTED INCIDENT OF HOSPITALIZATION. THE NURSE REPORTED THAT ON (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS MANIFESTED BY ABDOMINAL PAIN AND CLOUDY FLUID AND WENT TO THE EMERGENCY ROOM FOR CARE. THE NURSE WAS UNABLE TO CLARIFY PD EFFLUENT CULTURE RESULTS, DUE TO TEST PERFORMED AT HOSPITAL. THE PATIENT WAS TREATED WITH VANCOMYCIN INTRAPERITONEAL INJECTION EVERY THREE DAYS (DOSE NOT REPORTED). ON AN UNREPORTED DATE, THE PATIENT WAS RETRAINED. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED A URINARY TRACT INFECTION (UTI). THE PATIENT WAS TREATED WITH UNKNOWN ANTIBIOTICS FOR THE UTI. THE PATIENT WAS RECOVERING FROM THE UTI. THE UTI WAS UNRELATED TO BAXTER PRODUCTS.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 1 OF 3 INVOLVED IN THIS EVENT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR H12F27030, H12F15035, AND H12D18117 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PROBLEM WAS NOT CONFIRMED AND THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT FROM A CONSUMER WITH SUPPLEMENTAL INFORMATION PROVIDED BY A NURSE IN THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX AND EXTRANEAL VIAFLEX THERAPIES. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED: ON (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED ON THE SAME DAY. CAUSE OF PERITONITIS WAS UNKNOWN. THE DOCTOR BELIEVED THAT THERE WAS NO BACTERIAL GROWTH AS THE PATIENT WAS ON UNSPECIFIED ANTIBIOTICS (DOSES AND FREQUENCIES NOT REPORTED) A WEEK BEFORE FOR AN UNREPORTED ISSUE. THE PATIENT WAS ON ORAL ANTIBIOTICS FOR EVERY FOUR DAYS THROUGHOUT THE DIALYSIS. ON AN UNREPORTED DATE, THE PATIENT CATHETER WAS MOVED FROM RIGHT TO LEFT AND THIS EPISODE OF PERITONITIS WAS THE FIRST INFECTION SINCE MOVED TO THE LEFT SIDE. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT RECOVERED. THE EVENT OF PERITONITIS WAS UNRELATED TO BAXTER PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R DIANEAL PD4 AMBUFLEX| EXTRANEAL VIAFLEX