BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2854822 · Received December 3, 2012

    Report

    Report Number
    1416980-2012-06316
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    October 1, 2012
    Report Date
    November 8, 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

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN; THEREFORE, DEVICE INFO IS 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 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 SPONTANEOUS REPORT FROM A CONSUMER WITH SUPPLEMENTAL INFORMATION PROVIDED BY A NURSE IN THE USA OF PERITONEAL DIALYSIS (PD) CATHETER INFECTION WITH CULTURE POSITIVE FOR CANDIDA, TOUCH CONTAMINATION, AND PERITONITIS WITH CULTURE POSITIVE FOR CANDIDA IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG THERAPIES. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG THERAPIES (DOSES, FREQUENCIES, AND LOT NUMBERS NOT REPORTED), INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER TECHNICAL SERVICES (BTS) REGARDING A LOW DRAIN VOLUME ALARM WITH THE HOMECHOICE (HC) DEVICE, THE FOLLOWING WAS REPORTED BY THE CAREGIVER (CG). ON AN UNREPORTED DATE, THE PATIENT WAS NOT DRAINING PROPERLY. THE BTS REPRESENTATIVE ADVISED OF POSSIBLE BLOCKAGE AND TO END THE THERAPY. ON AN UNREPORTED DATE, THE PATIENT WAS TAKEN TO THE HOSPITAL BECAUSE OF THE BLOCKAGE. THE CG STATED THAT THE PATIENT HAD A YEAST INFECTION (ONSET DATE NOT REPORTED) AND BELIEVED THAT IT MIGHT HAVE CONTRIBUTED TO THE DRAINING DIFFICULTY. THE CG ALSO STATED THAT THE DOCTOR HAD MENTIONED THAT THE PATIENT MIGHT HAVE TO GET THE CATHETER REPLACED. ON (B)(4) 2012, BAXTER GPV FOLLOWED UP WITH THE NURSE AND RECEIVED THE FOLLOWING ADDITIONAL INFORMATION AS FOLLOWS. ON AN UNREPORTED DATE IN (B)(6) 2012, THE PATIENT EXPERIENCED A PD CATHETER INFECTION. ON AN UNREPORTED DATE IN (B)(6) 2012, THE PATIENT BEGAN TREATMENT WITH AN UNSPECIFIED ANTIBIOTIC (ROUTE, DOSE, AND FREQUENCY UNKNOWN) FOR PD CATHETER INFECTION. ON AN UNREPORTED DATE IN (B)(6) 2012, THE PATIENT EXPERIENCED DRAINING DIFFICULTIES AND DECLINED TO HAVE A PD EFFLUENT CULTURE DONE DUE TO VACATION PLANS. ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED FOR A YEAST INFECTION (PREVIOUSLY REPORTED). DURING HOSPITALIZATION, THE YEAST INFECTION WAS DIAGNOSED AS PERITONITIS WITH CULTURE POSITIVE FOR CANDIDA (SPECIES UNKNOWN). TREATMENT RENDERED FOR THE PERITONITIS WAS NOT REPORTED. CONCOMITANT MEDICATION WAS NOT REPORTED. PER THE NURSE THE SOURCE OF CANDIDA INFECTION WAS FROM THE PD CATHETER INFECTION. ON AN UNREPORTED DATE, PD THERAPY WAS WITHDRAWN. ON (B)(6) 2012, THE PATIENT'S PD CATHETER WAS REMOVED AND HEMODIALYSIS WAS INITIATED. THE NURSE REPORTED, THE CAUSE OF PERITONITIS WAS A TOUCH CONTAMINATION (ONSET DATE AND DETAILS NOT REPORTED). IT WAS UNKNOWN WHETHER THE PATIENT WAS RETRAINED ON ASEPTIC PROCEDURE. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON HEMODIALYSIS. ON (B)(6) 2012, THE NURSE REPORTED THE PATIENT WAS RECOVERED FROM THE PERITONITIS. PER THE NURSE, THE CAUSE OF THE CATHETER INFECTION AND PERITONITIS WAS TOUCH CONTAMINATION AND NOT RELATED TO A BAXTER DEVICE 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 50 YR Hospitalization| R DIANEAL PD4 AMBUFLEX| DIANEAL PD4 ULTRABAG