BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 2133366 · Received June 20, 2011

    Report

    Report Number
    1423500-2011-07813
    Event Type
    Injury
    Date Received
    June 20, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 25, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    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 IS USE ERROR-POOR ASEPTIC TECHNIQUE. A BATCH REVIEW WAS PERFORMED FOR THE POTENTIALLY ASSOCIATED LOT NUMBER (GD882613). THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. A LABELING REVIEW WAS PERFORMED AND THE LABELING WAS FOUND TO PROVIDE AMPLE INSTRUCTIONS RELATED TO PREVENTION OF THE USE ERROR IN ASEPTIC TECHNIQUE. 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 2 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 WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM THE USA OF AND TOUCH CONTAMINATION AND PERITONITIS COINCIDENT WITH DIANEAL PD4 AMBUFLEX AND EXTRANEAL VIAFLEX THERAPIES. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX AND EXTRANEAL VIAFLEX (DOSES, FREQUENCIES, AND LOT NUMBERS NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, A BREAK IN ASEPTIC TECHNIQUE OCCURRED, DESCRIBED AS TOUCH CONTAMINATION. FURTHERMORE, THE BREAK IN ASEPTIC TECHNIQUE WAS ATTRIBUTED TO HAVE BEEN CAUSED BY ANTIBIOTICS, AND HAD "TURNED INTO A YEAST INFECTION." ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS CULTURE POSITIVE FOR STAPHYLOCOCCUS AND CANDIDA ALBICANS AND WAS HOSPITALIZED THE SAME DAY. TREATMENT WAS NOT REPORTED. THE PATIENT WAS DISCHARGED (B)(6) 2011. THE PATIENT WAS RECOVERING FROM PERITONITIS. THE OUTCOME FOR THE EVENT OF TOUCH CONTAMINATION WAS UNKNOWN. DIANEAL AND EXTRANEAL THERAPIES WERE WITHDRAWN ON AN UNREPORTED DATE. THE NURSE BELIEVED THE PERITONITIS WAS CAUSED BY TOUCH CONTAMINATION AND ANTIBIOTIC USE, WHICH TURNED INTO YEAST AND NOT RELATED TO DIANEAL AND EXTRANEAL THERAPIES. AN OPINION OF CAUSALITY WAS NOT REPORTED FOR THE TOUCH CONTAMINATION.

    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 65 YR Hospitalization DIANEAL PD4 AMBUFLEX| HOMECHOICE| EXTRANEAL VIAFLEX