BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1961922 · Received January 14, 2011

    Report

    Report Number
    1423500-2011-00670
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 20, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE 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 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THIS IS A SOLICITED REPORT BY A NURSE FROM (B)(6) OF ABDOMINAL DISCOMFORT, PERITONITIS, AND CLINICALLY UNWELL IN AN APPROXIMATELY (B)(6) FEMALE PATIENT COINCIDENT WITH EXTRANEAL VIAFLEX THERAPY (LOT NUMBER 10G06G37). ON (B)(6) 2010, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX, LOT#10G06G37, (DOSE AND FREQUENCY NOT REPORTED), INTRAPERITONEALLY (IP), FOR AUTOMATED PERITONEAL DIALYSIS (APD). ON (B)(6) 2010, THE PATIENT DEVELOPED A SUDDEN ONSET OF ABDOMINAL DISCOMFORT AND HAD DEVELOPED PERITONITIS (MANIFESTED BY CLOUDY EFFLUENT). THE PATIENT WAS FOUND TO BE "CLINICALLY UNWELL," AND WAS TREATED PER HOSPITAL PROTOCOL WITH VANCOMYCIN, 2G, 3X/WEEK, INTRAVENOUSLY (IV) AND CEFTAZIDIME, 1G, ONE TIME ONLY, IP. THE PERITONEAL DIALYSIS (PD) FLUID WAS DRAINED BY NON PD STAFF, AND THE FLUID WAS FOUND TO BE CLOUDY. ON THE SAME DAY, A PERITONEAL EFFLUENT LEUCOCYTE COUNT WAS PERFORMED WHICH REVEALED 24,700 CELLS/MM^3 AND MONOCYTES 5%. ON AN UNREPORTED DATE IN (B)(6) 2010, A PERITONEAL EFFLUENT GRAM STAIN WAS PERFORMED WHICH REVEALED GRAM POSITIVE COCCI. ON (B)(6) 2010, A PERITONEAL EFFLUENT CULTURE WAS PERFORMED WHICH REVEALED NO GROWTH. HOWEVER, DUE TO NON PD STAFF OBTAINING THE PD SAMPLE, A POSSIBLE CONTAMINATION OF THE PD FLUID MAY HAVE OCCURRED. THE PATIENT WAS NOT HOSPITALIZED AND CONTINUED REMEDIAL TREATMENT WITH VANCOMYCIN THROUGH (B)(6) 2010. THE PD FLUID HAD REMAINED CLEAR AND THE PATIENT HAD CONTINUED TO USE THE SAME EXTRANEAL BATCH NUMBER. ON AN UNREPORTED DATE, THE PATIENT RECOVERED FROM THE EVENT OF PERITONITIS; HOWEVER THE OUTCOME OF THE EVENTS OF "CLINICALLY UNWELL" AND ABDOMINAL DISCOMFORT WERE NOT REPORTED. THE SAME BATCH NUMBER OF EXTRANEAL REMAINED ONGOING WITHOUT REOCCURRENCE OF PERITONITIS. THE ROOT CAUSE OF THE PERITONITIS WAS DUE TO NO DISCERNABLE CAUSE, AND THE SEVERITY WAS CONSIDERED MILD. THE REPORTER DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENTS OF ABDOMINAL DISCOMFORT, PERITONITIS, AND "CLINICALLY UNWELL." CONCOMITANT MEDICATIONS WERE NOT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R