BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2935017 · Received January 30, 2013

    Report

    Report Number
    1416980-2013-02259
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 23, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON AN UNKNOWN DATE, THE PERITONEAL EFFLUENT WAS ANALYZED AND SHOWED A LEUCOCYTE COUNT OF GREATER THAN 8000 (UNITS NOT SPECIFIED). ON AN UNKNOWN DATE, A PERITONEAL EFFLUENT CULTURE WAS PERFORMED AND WAS FOUND TO BE POSITIVE FOR ENTEROBACTER. THE PATIENT WAS TREATED WITH CEFTAZIDIME 125MG/L NIGHTLY IP FROM (B)(6) 2013. THE RN FELT THE CAUSE OF THE PERITONITIS WAS THE PERITONEAL EFFLUENT SAMPLE WAS COLLECTED WITHOUT USING PROPER ASEPTIC TECHNIQUE WHEN THE PATIENT WAS HOSPITALIZED ON (B)(6) 2013 FOR LOW BLOOD PRESSURE AND HIGH CALCIUM LEVELS.

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE WAS NOT REQUESTED BECAUSE PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY AND THERE WAS NO ALLEGATION AGAINST THE DEVICE. THIS COMPLAINT FOR PERITONITIS IS NOT CONFIRMED BECAUSE THE DISPOSABLE SET WAS NOT RETURNED TO BAXTER AND THE COMPLAINT INVESTIGATION DID NOT DESCRIBE ANY TYPES OF USE ERRORS OR PRODUCT MALFUNCTION THAT MIGHT HAVE CAUSED POTENTIAL CONTAMINATION. THEREFORE, THE COMPLAINT IS NOT CONFIRMED AND THE ASSIGNABLE CANNOT BE DETERMINED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR ASSOCIATED LOT NUMBERS H12J28015 AND H12K27031 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. 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

    DURING FOLLOW UP WITH THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) ON (B)(6) 2013 FOR AN UNRELATED REPORT, THE PDRN REPORTED THE PATIENT HAD BEEN RE-HOSPITALIZED IN THE THIRD WEEK OF (B)(6) 2013 (DATE NOT SPECIFIED) AND DIAGNOSED WITH PERITONITIS. PER THE PDRN, THE PATIENT HAD BEEN HOSPITALIZED PRIOR TO THIS PERITONITIS EVENT (UNREPORTED DATE IN (B)(6) 2013) FOR UNRELATED ISSUES AND HAD BEEN DISCHARGED. THE HOSPITAL WAS VERY UNFAMILIAR WITH PERFORMING PD THERAPY AND THE PDRN FELT THAT THIS MAY HAVE CAUSED THE PERITONITIS. THE PATIENT WAS TREATED WITH ANTIBIOTICS (NAME, DOSE, ROUTE, AND FREQUENCY NOT REPORTED). THE PATIENT WAS REPORTED TO BE HOME AND IS CONSIDERED TO BE RECOVERING FROM THIS EVENT OF PERITONITIS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40814 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization| R DIANEAL PD2