BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2122395 · Received June 13, 2011

    Report

    Report Number
    1423500-2011-07544
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 20, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS WAS UNDETERMINED. A BATCH REVIEW WAS PERFORMED FOR THE POTENTIALLY ASSOCIATED LOT NUMBERS (H11A18056, H11C13483, H11D08036). THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS REPORT 1 OF 2 INVOLVED IN THIS PERITONITIS EVENT. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE. THIS IS A SPONTANEOUS REPORT BY A CONSUMER FROM (B)(4) OF PERITONITIS COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY. ON AN UNREPORTED DATE IN 2010, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX THERAPY (DOSE, FREQUENCY, AND LOT NUMBER NOT REPORTED) INTRAPERITONEALLY FOR PERITONEAL DIALYSIS. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE CONSUMER REPORTED THE FOLLOWING. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED THAT SAME DAY. FURTHER DETAILS AND TREATMENT WERE NOT REPORTED. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON AN UNREPORTED DATE, PD THERAPY WAS DISCONTINUED. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND HE WAS RECOVERING. AN OPINION OF CAUSALITY WAS NOT REPORTED.

    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 55 YR Hospitalization HOMECHOICE DEVICE| DIANEAL PD4 AMBUFLEX