BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1893911 · Received November 9, 2010

    Report

    Report Number
    1423500-2010-05500
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 18, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT WAS APPROXIMATELY (B)(6). 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. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A BAXTER (B)(4) FROM (B)(6) OF DID NOT WEAR A MASK, FEVER, AND BACTERIAL PERITONITIS WITH (B)(6) IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON AN UNREPORTED DATE, THE PATIENT DID NOT WEAR A MASK. ON (B)(6) 2010, THE PATIENT DEVELOPED PERITONITIS, MANIFESTED BY ABDOMINAL PAIN, CLOUDY EFFLUENT, AND FEVER. THE CAUSE OF THE PERITONITIS WAS THAT THE PATIENT DID NOT WEAR A MASK. THE PATIENT RECEIVED REMEDIAL TREATMENT WITH UNSPECIFIED ANTIBIOTICS. THE PERITONITIS WAS ONGOING AND IMPROVED. THE OUTCOMES OF THE FEVER AND EVENT OF DID NOT WEAR A MASK WERE NOT REPORTED. PD THERAPY WAS ONGOING. THE REPORTER BELIEVED THE PERITONITIS WAS UNRELATED TO DIANEAL THERAPY AND DID PROVIDE AN OPINION OF CAUSALITY FOR THE FEVER OR THE EVENT OF DID NOT WEAR A MASK.

    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 Required Intervention DIANEAL