BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2853407 · Received November 30, 2012

    Report

    Report Number
    1416980-2012-06280
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    October 1, 2012
    Report Date
    November 7, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A 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. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED. NO ASSIGNABLE CAUSE WAS DETERMINED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT FROM A NURSE WITH SUPPLEMENTAL INFORMATION FROM A PHYSICIAN IN THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL UNKNOWN THERAPY FOR PERITONEAL DIALYSIS (PD). ACTION TAKEN WITH THE DIANEAL THERAPY WAS UNKNOWN. DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE FOLLOWING INFORMATION WAS PROVIDED. ON AN UNKNOWN DATE IN (B)(6) 2012, THE PATIENT DEVELOPED PERITONITIS. IT WAS UNKNOWN IF THE PATIENT WAS HOSPITALIZED FOR THE EVENT. PER THE NURSE, THE PATIENT CAME IN WITH A VERY HIGH PD FLUID CELL COUNT. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH GENTAMICIN AND VANCOMYCIN FOR THE EVENT. THREE DAYS AFTER THE START OF TREATMENT, THE PATIENT'S CELL COUNT NORMALIZED AND THE PD FLUID REMAINED CLEAR. ON AN UNREPORTED DATE A PERITONEAL EFFLUENT CULTURE WAS TAKEN WITH RESULTS POSITIVE FOR ELIZABETHKINGIA MENINGOSEPTICUM. ON AN UNREPORTED DATE A REPEAT CULTURE WAS PERFORMED WITH RESULTS POSITIVE FOR COMAMONAS TESTOSTERONI. THE PHYSICIAN BELIEVED THAT THE REMOVAL OF THE CATHETER MAY BE THE BEST WAY TO TREAT THE ORGANISMS. PER THE NURSE, POOR HYGIENE MAY HAVE CAUSED THE GROWTH OF THE COMAMONAS TESTOSTERONI. PER THE NURSE, THE PATIENT HAD RECOVERED FROM THE PERITONITIS PRIOR TO THE CULTURES GROWING THE ORGANISMS. AN OPINION OF CAUSALITY WAS NOT REPORTED FOR THE EVENTS.

    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 Required Intervention HOMECHOICE| DIANEAL UNKNOWN