BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2830732 · Received November 13, 2012

    Report

    Report Number
    1416980-2012-05027
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 31, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THIS COMPLAINT FOR A REPORT OF USE ERROR - BREACH IN ASEPTIC TECHNIQUE IS CONFIRMED, BECAUSE IT WAS REPORTED THAT THERE WAS A BREACH IN ASEPTIC TECHNIQUE, DESCRIBED AS TOUCH CONTAMINATION; HOWEVER, THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED, SINCE IT IS UNSURE WHY THE PATIENT HAD A BREACH IN ASEPTIC TECHNIQUE. A LABELING REVIEW HAS BEEN PERFORMED, FINDING THAT CURRENT LABELING PROVIDES AMPLE INSTRUCTIONS RELATED TO THE PREVENTION OF THE USE ERROR IN THIS REPORT. THE LABELING REVIEW CONFIRMED, INSTRUCTIONS RELEVANT TO THE COMPLAINT ARE DOCUMENTED IN THE PRODUCT LABELING AND ARE EASILY ACCESSIBLE TO THE USER.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS SUPPLIED BY A NURSE AS FOLLOWS. ON (B)(6) 2009, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX 2 LITERS DAILY, PHYSIONEAL 40, 1.36%, 4 LITERS PER DAY AND PHYSIONEAL 40, 3.86%, 2 LITERS DAILY (LOT NUMBERS NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS VIA CAPD (CONTINUOUS AMBULATORY PERITONEAL DIALYSIS). ON AN UNREPORTED DATE THE PATIENT BEGAN PHYSIONEAL 40, 1.36%, 2 LITERS, TWICE DAILY. AT THE TIME OF THIS REPORT, EXTRANEAL AND PHYSIONEAL THERAPIES WERE ONGOING (DOSES NOT CHANGED). ON AN UNREPORTED DATE, A BREAK IN ASEPTIC TECHNIQUE OR TOUCH CONTAMINATION OCCURRED. ON (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS MANIFESTED AS CLOUDY EFFLUENT AND ABDOMINAL PAIN. THE PATIENT DID NOT REQUIRE HOSPITALIZATION. ON (B)(6) 2012, THE PATIENT BEGAN REMEDIAL THERAPY WITH VANCOMYCIN, 1 GRAM, IP (3/3 DAYS) AND GENTAMICIN, 80MG, IP DAILY FOR THE BACTERIAL PERITONITIS. ON AN UNREPORTED DATE, THE BACTERIAL PERITONITIS WITH (B)(6) WAS RESOLVED. ON (B)(6) 2012, GENTAMICIN THERAPY WAS DISCONTINUED. ON (B)(6) 2012, VANCOMYCIN THERAPY WAS DISCONTINUED. PER THE NURSE, ON (B)(6) 2012 THE PATIENT RECEIVED RE-TRAINING ON THE TECHNIQUE OF WASHING AND DISINFECTING HANDS. THE NURSE REPORTED THE CAUSE OF THE PERITONITIS WAS RELATED TO THE BREAK IN ASEPTIC TECHNIQUE OR TOUCH CONTAMINATION AND UNRELATED TO EXTRANEAL AND PHYSIONEAL THERAPIES.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN; THEREFORE, MANUFACTURER SITE IS UNKNOWN. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. 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. 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. THE PROBLEM WAS NOT CONFIRMED AND THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT FROM A NURSE IN (B)(6) OF PERITONITIS IN A PATIENT COINCIDENT WITH UNKNOWN SOLUTIONS FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED PERITONITIS. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED. TREATMENT WAS NOT REPORTED. THE OUTCOME OF THIS PERITONITIS REPORT WAS UNKNOWN. PER THE NURSE, THIS PERITONITIS EVENT WAS UNRELATED TO BAXTER PRODUCTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other| R FOLIC ACID| IRON| PHYSIONEAL 40, 1.36%| ERYTHROPOIETIN| B-COMPLEX| ACETYLSALICYLIC ACID| PANTOPRAZOLE (PANTOC)| PHYSIONEAL 40, 3.86%| ALFACALCIDOL| EXTRANEAL VIAFLEX| INSULIN (INSULATARD)| INSULIN (ACTRAPID)| DECADURABOLIN| DOMPERIDONE| NAFTIDROFURYL (PRAXILENE)| FLUOXETINE| MAGNESIUM (MAGNESIOCARD)