BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2833934 · Received November 15, 2012

    Report

    Report Number
    1416980-2012-05260
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 29, 2012
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION:THE PROBLEM WAS NOT CONFIRMED AND THE CAUSE OF THE PERITONITIS COULD NOT BE DETERMINED, AS NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED DURING THE REPORT.

    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. 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 ASSOCIATED LOT NUMBERS GD892950, GD892828, AND GD892638 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS WERE NOTED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION FROM A NURSE IN THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL ULTRABAG 2.5% THERAPY. PERITONEAL DIALYSIS THERAPY WAS ONGOING. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. THE CAUSE OF PERITONITIS WAS UNKNOWN. THE PATIENT WAS RETRAINED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(4) 2012. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS. THE PATIENT IS RECOVERING. THE EVENT WAS NOT RELATED TO HCS MACHINE, DISPOSABLE PARTS, OR DIANEAL THERAPY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization| R DIANEAL ULTRABAG 2.5%