BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2883405 · Received December 21, 2012

    Report

    Report Number
    1416980-2012-07924
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 26, 2012
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. A 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. A SAMPLE WAS NOT REQUESTED BECAUSE THE EVENT INVOLVED USE ERROR AND THERE WAS NO ALLEGATION AGAINST THE DEVICE. THIS COMPLAINT IS FOR A REPORT OF A USE ERROR - BREACH IN ASEPTIC TECHNIQUE AND PERITONITIS. THE COMPLAINT IS CONFIRMED BECAUSE THE NURSE REPORTED BREAK IN ASEPTIC TECHNIQUE BY PATIENT DESCRIBED AS TOUCH CONTAMINATION. THE ASSIGNABLE CAUSE FOR THE BREAK IN ASEPTIC TECHNIQUE IS NOT DETERMINED. A LABELING REVIEW WAS PERFORMED WHICH FOUND THE LABELING ADEQUATE FOR THE PREVENTION OF THE USE ERROR IN THIS COMPLAINT. THE LABELING REVIEW CONFIRMED, INSTRUCTIONS RELEVANT TO THE COMPLAINT ARE DOCUMENTED IN THE PRODUCT LABELING AND ARE EASILY ACCESSIBLE TO THE USER. 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.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED BY BAXTER GLOBAL PHARMACOVIGILANCE (GPV) AND IS A REPORT FROM A CONSUMER WITH SUPPLEMENTAL INFORMATION RECEIVED FROM A NURSE IN THE USA OF PATIENT MADE MISTAKE, TOUCH CONTAMINATION, AND PERITONITIS WITH CULTURE POSITIVE FOR ESCHERICHIA COLI (E-COLI) AND ENTEROBACTER CLOACAE IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX, DIANEAL PD4 ULTRABAG AND EXTRANEAL VIAFLEX THERAPIES. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX, DIANEAL PD4 ULTRABAG AND EXTRANEAL VIAFLEX THERAPIES (DOSES, FREQUENCIES AND LOT NUMBERS NOT REPORTED), INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). AT THE TIME OF THE INITIAL REPORT, DIANEAL THERAPIES WERE ONGOING. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED BY THE CONSUMER. ON AN UNREPORTED DATE, THE PATIENT MADE A MISTAKE OF TOUCH CONTAMINATION (DETAILS NOT PROVIDED). ON (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS. ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. ON AN UNREPORTED DATE, PERITONEAL EFFLUENT CULTURE WAS PERFORMED FOR WHICH THE RESULTS WERE UNKNOWN. TREATMENT WAS NOT REPORTED. AT THE TIME OF THIS REPORT THE PATIENT REMAINED HOSPITALIZED BUT WAS RECOVERING. ON (B)(6) 2012 FURTHER INFORMATION WAS RECEIVED FROM A NURSE. THE NURSE CLARIFIED THE START DATE OF THE PERITONITIS WAS ACTUALLY (B)(4) 2012 (CONTRARY TO THE DATE REPORTED BY THE CONSUMER) AND CONFIRMED THE DATE OF HOSPITALIZATION AS REPORTED. THE NURSE REPORTED, ON (B)(6) 2012, THE PATIENT'S PD CATHETER WAS REMOVED AND ON THE SAME DATE, DIANEAL AND EXTRANEAL THERAPIES WERE DISCONTINUED. THE NURSE REPORTED, ON (B)(6) 2012, PD THERAPY WAS DISCONTINUED PERMANENTLY AND THE PATIENT WAS SWITCHED TO HEMODIALYSIS. THE NURSE STATED THE PATIENT WAS STILL HOSPITALIZED. ON (B)(6) 2012 PRODUCT SURVEILLANCE CONTACTED THE PD NURSE (PDN) AND RECEIVED THE FOLLOWING ADDITIONAL INFORMATION. THE PDN CLARIFIED THE REASON THE PATIENT WAS PERMANENTLY TAKEN OFF PD THERAPY WAS DUE TO OTHER HEALTH ISSUES (UNSPECIFIED) AND NOT RELATED TO THE PERITONITIS EVENT. THE PDN CONFIRMED THE CAUSE OF THE PERITONITIS WAS THE PATIENT MADE A TOUCH CONTAMINATION. THE PDN CONFIRMED THE CAUSE OF THE PERITONITIS WAS NOT RELATED TO A BAXTER PRODUCT OR SOLUTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization DIANEAL PD4 AMBUFLEX| EXTRANEAL VIAFLEX| DIANEAL PD4 ULTRABAG