BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1840927 · Received September 22, 2010

    Report

    Report Number
    1423500-2010-03614
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    August 1, 2010
    Report Date
    September 2, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS OPENED TO ADDRESS A PATIENT REACTION OF PERITONITIS. ROOT CAUSE FOR THE PERITONITIS WAS NOT IDENTIFIED DUE TO INSUFFICIENT INFORMATION AVAILABLE. SINCE NO SAMPLE WAS AVAILABLE FOR EVALUATION, NO ROOT CAUSE CAN BE DETERMINED THROUGH SAMPLE INSPECTION. NO SPECIFIC PRODUCT FAILURES WERE INDICATED IN THE COMPLAINT REPORT THAT COULD CONTRIBUTE TO PERITONITIS. A BATCH REVIEW WAS PERFORMED FOR SUSPECT LOT NUMBERS, WITH NO DEFECTS NOTED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENT DISCARDS SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED.BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    DURING EVALUATION OF THE HOMECHOICE (HC) DEVICE, THE (B)(4) DETERMINED THE HC MACHINE SYSTEM FAILED RETURNED INSTRUMENT TEST/EVALUATION TESTING DUE TO THE FOLLOWING FAILURE: GROUND BOND FAILED PERFORMANCE SPECIFICATION. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE PATIENT'S DIALYSIS PRODUCTS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A CONSUMER FROM THE USA OF PERITONITIS AND MELANOMA IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE REPORTING CONSUMER STATED THAT ON AN UNKNOWN DATE, THE PATIENT WAS DIAGNOSED WITH PERITONITIS AND MELANOMA. ON (B)(6)2010, THE PATIENT WAS HOSPITALIZED FOR "SEVERAL THINGS, THE BIGGEST CONCERN WAS MELANOMA AND HE WAS TREATED FOR PERITONITIS WHICH WAS NOT WORRISOME." TREATMENT INFORMATION WAS NOT PROVIDED FOR THE EVENTS. PD THERAPY WAS ONGOING AT THE TIME OF THE EVENTS. THE PATIENT WAS RECOVERING FROM THE EVENTS. ON (B)(6)2010, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R DIANEAL PD4 AMBUFLEX