BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1860572 · Received October 7, 2010

    Report

    Report Number
    1423500-2010-04117
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    August 1, 2010
    Report Date
    September 13, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER

    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 SPONTANEOUS REPORT BY A NURSE FROM THE (B)(6) OF FUNGAL PERITONITIS WITH (B)(6) IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH FUNGAL PERITONITIS WITH (B)(6), MANIFESTED BY CLOUDY DIALYSATE AND ABDOMINAL PAIN. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2010 FOR THE FUNGAL PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON AN UNKNOWN DATE, THE PATIENT WAS TREATED WITH GENTAMYCIN 4MG/L PSD. ON (B)(6) 2010, THE PATIENT STARTED ON HEMODIALYSIS. ON (B)(6) 2010, THE PATIENT HAD HER PERITONEAL DIALYSIS CATHETER REMOVED. IT WAS UNKNOWN IF THE PERITONITIS RESOLVED.

    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 67 YR Hospitalization| R CALCIUM CARBONATE, EPOETIN| DIANEAL PD2, CIPROFLOXIN, FERROUS SULFATE