BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3250913 · Received July 29, 2013

    Report

    Report Number
    1416980-2013-19951
    Event Type
    Injury
    Date Received
    July 29, 2013
    Report Date
    July 2, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 DEVICE WAS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL OR RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H12J26076, H12K09112, H12K14047, H12L13070, H13B07048, H13C07061, H12J11037, AND H13C11048. ALL RELEASE CRITERIA WERE MET PRIOR TO THE RELEASE OF THESE LOTS. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED RECURRING PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT HAD BEEN HOSPITALIZED FOR SEVERE BACK PAIN AND LATER WAS DIAGNOSED WITH PERITONITIS. AFTER THE TREATMENT WITH ZYVOX, ORAL (DOSE AND FREQUENCY NOT REPORTED), THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT THEN EXPERIENCED A RECURRENCE OF PERITONITIS. THE PATIENT'S CATHETER WAS REMOVED AND THE PATIENT WAS PUT ON HEMODIALYSIS (HD) THERAPY. THE PATIENT WAS AGAIN HOSPITALIZED AND TREATED WITH ZYVOX (DOSE AND FREQUENCY NOT REPORTED). OUTCOME OF PERITONITIS WAS NOT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME. THIS IS REPORT 2 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353930 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL PD4 AMBUFLEX