BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1820441 · Received August 30, 2010

    Report

    Report Number
    1423500-2010-03009
    Event Type
    Injury
    Date Received
    August 30, 2010
    Date of Event
    August 6, 2010
    Report Date
    August 6, 2010
    Manufacturer
    UNKNOWN MANUFACTURING FACILITY
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A PHYSICIAN FROM (B)(4) REGARDING BACTERIAL PERITONITIS IN A (B)(6) MALE HOMECHOICE PERITONEAL DIALYSIS (PD) PATIENT. ON AN UNREPORTED DATE, A BREAK IN ASEPTIC TECHNIQUE OCCURRED. ON (B)(6) 2010, THE DISTRIBUTOR CONTACTED BAXTER (B)(4) TECHNICAL SERVICE CENTER AND REPORTED THAT A PHYSICIAN ADVISED HIM THAT THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. A FOLLOW UP FROM THE PHYSICIAN REVEALED THAT IN (B)(6) 2010, THE PATIENT WAS HOSPITALIZED FOR BACTERIAL PERITONITIS, MANIFESTED BY CLOUDY EFFLUENT AND ABDOMINAL PAIN. ON (B)(6) 2010, A PERITONEAL EFFLUENT CULTURE REVEALED STAPHYLOCOCCUS AUREUS. ON THAT SAME DATE, THE PATIENT WAS TREATED WITH GENTACIN AND ROCEPHIN. THE BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR STAPHYLOCOCCUS AUREUS WAS RESOLVING. MEDICAL HISTORY INCLUDED RENAL FAILURE CHRONIC, AND GLOMERULONEPHRITIS CHRONIC. THE REPORTER BELIEVED THE BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR STAPHYLOCOCCUS AUREUS WAS NOT RELATED TO PD THERAPY.

    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 75 Hospitalization| R DIANEAL UNKNOWN