BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2122400 · Received June 13, 2011

    Report

    Report Number
    1423500-2011-07548
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    February 1, 2011
    Report Date
    May 20, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    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 NUMBER (H10H31055). 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 3 OF 3 INVOLVED IN THIS PERITONITIS EVENT. THE SAMPLE IS NOT AVAILABLE. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM (B)(6). THIS IS A SPONTANEOUS REPORT BY A CONSUMER FROM (B)(6) OF PERITONITIS COINCIDENT WITH DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG THERAPIES. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG (DOSES, FREQUENCIES AND LOT NUMBERS NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). 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. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. TREATMENT WAS NOT REPORTED. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON AN UNREPORTED DATE IN 2011, THE PATIENT HAD RECOVERED. DIANEAL THERAPIES WERE ONGOING. AN OPINION OF CAUSALITY WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization DIANEAL PD4 AMBUFLEX| HOMECHOICE DEVICE| DIANEAL PD4 ULTRABAG