BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1812035 · Received August 24, 2010

    Report

    Report Number
    1423500-2010-02799
    Event Type
    Injury
    Date Received
    August 24, 2010
    Date of Event
    July 1, 2010
    Report Date
    August 4, 2010
    Manufacturer
    UNKNOWN MANUFACTURING FACILITY
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)-SINCE NO SAMPLE WAS AVAILABLE FOR EVALUATION, THE ROOT CAUSE CANNOT BE DETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS AND WILL CONTINUE TO MONITOR THESE REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THIS MDR WAS SUBMITTED ON 01/14/2011; HOWEVER, DUE TO A FAILED ACK3, THIS MDR IS BEING RESUBMITTED ON 01/14/2011.

    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.

    Description of Event or Problem · 1

    THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE UNKNOWN ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A BAXTER EMPLOYED NURSE FROM (B)(4) REGARDING A FEMALE PATIENT APPROXIMATELY (B)(6) COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. ON (B)(6) 2010, THE PATIENT DEVELOPED PERITONITIS, MANIFESTED BY ABDOMINAL PAIN, CLOUDY EFFLUENT, FEVER, AND VOMITING. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. ON (B)(6) 2010, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS FOR THE PERITONITIS. THE PERITONITIS WAS ONGOING AND IMPROVED. THE OUTCOMES OF THE FEVER AND VOMITING WERE NOT REPORTED. PERITONEAL DIALYSIS THERAPY WAS ONGOING. THE REPORTER BELIEVED THE PERITONITIS WAS UNRELATED TO PERITONEAL DIALYSIS THERAPY AND DID NOT PROVIDE AN ASSESSMENT OF CAUSALITY FOR THE FEVER AND VOMITING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ UNKNOWN MANUFACTURING FACILITY

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R DIANEAL PD4 UNK BAG