BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2855179 · Received December 3, 2012

    Report

    Report Number
    1416980-2012-06392
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 16, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. THE PRODUCT CODE IS UNKNOWN, THEREFORE 510K NUMBER IS UNKNOWN. 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; HOWEVER, THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED, SINCE IT IS UNSURE WHY THE PATIENT HAD A BREACH IN ASEPTIC TECHNIQUE. A LABELING REVIEW FOUND THE LABELING TO BE ADEQUATE FOR THE PREVENTION OF THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. 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 FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS IN AN PATIENT COINCIDENT WITH DIANEAL PD2 1.5% AND 2.5% THERAPIES. ON (B)(6) 2012, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 1.5% AND 2.5% THERAPIES (DOSE, FREQUENCY, AND LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ACTION TAKEN WITH DIANEAL THERAPY WAS NOT REPORTED. ON AN UNREPORTED DATE, THE PATIENT HAD BREAK IN ASEPTIC TECHNIQUE. ON (B)(6) 2012, THE PATIENT WAS DIAGNOSED WITH AND HOSPITALIZED FOR PERITONITIS MANIFESTED BY ABDOMINAL PAIN AND CLOUDY EFFLUENT. THE CAUSE OF THE PERITONITIS WAS THE BREAK IN ASEPTIC TECHNIQUE. THE PATIENT WAS TREATED WITH VANCOMYCIN 500MG IN 100CC OF PLAIN NORMAL SALINE SOLUTION (PNSS) AND CIPROFLOXACIN 500MG TWICE DAILY (ROUTES NOT REPORTED) FOR THE PERITONITIS. THE PATIENT WAS RE-TRAINED. THE OUTCOME OF THE PERITONITIS WAS NOT REPORTED.

    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 81 YR Hospitalization| R DIANEAL PD2 2.5%| DIANEAL PD2 1.5%