BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3031300 · Received April 2, 2013

    Report

    Report Number
    1416980-2013-08125
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 10, 2013
    Report Date
    March 14, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. 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 CAUSE COULD BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(4) 2013, FOLLOW UP INFORMATION WAS RECEIVED RELATED TO THIS EVENT. IT WAS REPORTED THAT THERAPY WITH CEFTAZIDIME, CEFAZOLIN AND FLUCONAZOLE WAS DISCONTINUED AND THE PATIENT BEGAN TREATMENT WITH LINEZOLID. ON A LATER DATE, TREATMENT WITH LINEZOLID ENDED AND THE PATIENT WAS TO START TREATMENT WITH BACTRIM THE NEXT DAY. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH THERAPY FOR END STAGE RENAL DISEASE (ESRD). THERAPY WAS ON-GOING. AS A RESULT OF THE PERITONITIS, THE PATIENT EXPERIENCED CLOUDY EFFLUENT. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. IT WAS UNKNOWN IF THE PATIENT WAS HOSPITALIZED FOR THE EVENTS. ON THE SAME DAY, AN ABDOMINAL ULTRASOUND WAS PERFORMED AND REVEALED A PERITONEAL CATHETER TUNNEL INFECTION. THE PATIENT WAS TREATED WITH CEFTAZIDIME, CEFAZOLINE AND FLUCONAZOLE FOR THE EVENTS. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE PERITONITIS. THE OUTCOME OF THE CATHETER TUNNEL INFECTION WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134752 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention RAMIPRIL, PARICALCITOL, SEVELAMER, CINACALCET| ADALAT, PHYSIONEAL 40 1.36% AND EXTRANEAL