BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3082248 · Received April 29, 2013

    Report

    Report Number
    1416980-2013-10640
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    March 28, 2013
    Report Date
    April 5, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION RECEIVED FROM A NURSE: ON AN UNREPORTED DATE, THREE DAYS AFTER USING ANTIBIOTICS, THE PATIENT DID NOT EXPERIENCE ABDOMINAL PAIN AND FLUID WAS TRANSPARENT. THE PERITONEAL EFFLUENT CELL COUNT WAS NOT PERFORMED AGAIN. THE PATIENT STOPPED TREATMENT WITH ANTIBIOTICS AND WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT RECOVERED FROM THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    THIS IS A REPORT OF PERITONITIS, DIARRHEA, AND TENDERNESS IN A PATIENT COINCIDENT WITH DIANEAL THERAPY FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). DIANEAL THERAPY WAS ONGOING. THE PATIENT HAD DIARRHEA. THE NEXT DAY THE PATIENT HAD TENDERNESS AND WAS ALSO DIAGNOSED WITH PERITONITIS MANIFESTED BY MUDDY EFFLUENT AND FEVER. THE PATIENT WAS HOSPITALIZED FOR TENDERNESS AND PERITONITIS. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. THE PATIENT WAS TREATED WITH CEFAZOLINE (250MG 4 TIMES A DAY), TIENAM (200MG 4 TIMES A DAY), AND CIPRO BAY (50MG 4 TIMES A DAY) ROUTES NOT REPORTED. THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183551 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R DIANEAL 1.5%