BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2033554 · Received March 30, 2011

    Report

    Report Number
    1423500-2011-03830
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 8, 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). A BATCH REVIEW WAS CONDUCTED ON POTENTIALLY ASSOCIATED LOT NUMBERS H10F23064, H10G26065, H10I22029 AND H10G30067 WITH NO DEFECTS NOTED. THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SPECIFIC PRODUCT CODE FOR THE MINICAP TRANSFER SET IS UNKNOWN. THE BRAND NAME AND 510K HAVE BEEN PROVIDED IN THIS MDR. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN THE SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 3 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS CONSUMER REPORT FROM THE USA OF PERITONITIS WITH CULTURE POSITIVE FOR E. COLI IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG THERAPIES FOR PERITONEAL DIALYSIS (PD). DURING A CALL TO BAXTER CUSTOMER SERVICE, THE CONSUMER REPORTED THE FOLLOWING. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED ON THE SAME DAY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. TREATMENT FOR THE PERITONITIS WAS NOT REPORTED. ON AN UNREPORTED DATE, DIANEAL THERAPY WAS WITHDRAWN AND THE PATIENT WAS TRANSFERRED TO IN CENTER HEMODIALYSIS. THE PATIENT'S PD CATHETER HAS BEEN PULLED AND SHE MAY COME BACK TO PD AFTER 8 WEEKS OF RECOVERING. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING. THE REPORTER STATED THAT THE EVENT OF PERITONITIS WITH CULTURE POSITIVE FOR E. COLI WAS UNRELATED 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 78 YR Hospitalization DIANEAL PD4 ULTRABAG| DIANEAL PD4 AMBUFLEX| HOMECHOIC