BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2013609 · Received March 10, 2011

    Report

    Report Number
    1423500-2011-03002
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 16, 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 CAUSE F FOR THE REPORT OF PERITONITIS WAS DUE TO USE ERROR, POOR ASEPTIC TECHNIQUE. A LABELING REVIEW WAS PERFORMED AND FOUND TO BE ADEQUATE. A BATCH REVIEW WAS PERFORMED FOR THE POTENTIALLY ASSOCIATED LOT NUMBERS (H10G30067, H10H31055, H10I30048), WITH NO DEFECTS NOTED. 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 4 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 UPON COMPLETION OF BAXTER'S INVESTIGATION.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED BY GLOBAL PHARMACOVIGILANCE. THIS IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION BY A NURSE IN THE USA OF DIARRHEA AND PERITONITIS COINCIDENT WITH DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG THERAPIES. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX (DOSE, FREQUENCY NOT REPORTED) AND DIANEAL PD4 ULTRABAG (DOSE, FREQUENCY NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE CONSUMER REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2011, THE PATIENT EXPERIENCED DIARRHEA AND PERITONITIS. TREATMENT AND OUTCOME FOR THE DIARRHEA AND PERITONITIS WERE NOT REPORTED. ON AN UNREPORTED DATE IN (B)(6) 2011, THE PATIENT RECOVERED. IT WAS NOT REPORTED WHETHER OR IF DIANEAL THERAPIES WERE ONGOING. THE NURSE BELIEVED THAT THE EVENT OF PERITONITIS WITH CULTURE POSITIVE FOR ESCHERICHIA COLI WAS NOT RELATED TO DIANEAL THERAPIES.

    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 64 YR Other HOMECHOICE DEVICE| DIANEAL PD4 AMBUFLEX