BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1800336 · Received August 16, 2010

    Report

    Report Number
    1423500-2010-02514
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 27, 2010
    Manufacturer
    UNKNOWN MANUFACTURING FACILITY
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 CONSUMER REPORT FROM (B)(4) RECEIVED ON (B)(4) 2010 OF THE AREA NOT BEING CLEANED BEFORE STARTING PERITONEAL DIALYSIS (PD) AND PERITONITIS IN A (B)(6) MALE PATIENT COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY. IN (B)(6) 2010, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 ULTRABAG THERAPY, (DOSE AND FREQUENCY NOT REPORTED), INTRAPERITONEALLY (IP), FOR PD. ON AN UNREPORTED DATE, A BREAK IN ASEPTIC TECHNIQUE OCCURRED, DESCRIBED AS THE AREA NOT BEING CLEANED BEFORE STARTING PD. ON (B)(6) 2010, THE PATIENT DEVELOPED PERITONITIS, NOT REQUIRING HOSPITALIZATION. ON THE SAME DAY, A PERITONEAL EFFLUENT CULTURE WAS PERFORMED WHICH REVEALED NO GROWTH AND A PERITONEAL EFFLUENT ANALYSIS WAS PERFORMED WHICH REVEALED A LEUCOCYTE COUNT OF 21,500 CELLS/MM, NEUTROPHILS 90%, LYMPHOCYTES 8% AND MONOCYTES 2%. ON (B)(6) 2010, THE PATIENT WAS TREATED WITH A LOADING DOSE IP INJECTION OF VANCOMYCIN 1 GRAM (GM) AND CONTINUING DAILY IP INJECTIONS OF FORTUM 1GM AND AMIKACIN 500 MILLIGRAM (MG). THE OUTCOME OF THE EVENT OF PERITONITIS WAS UNKNOWN. IT WAS NOT REPORTED WHETHER THE PATIENT WAS RETRAINED IN ASEPTIC TECHNIQUE, THEREFORE THE OUTCOME OF THE EVENT OF THE AREA NOT BEING CLEANED BEFORE STARTING PD WAS UNKNOWN. THE ROOT CAUSE OF THE PERITONITIS WAS DUE TO THE AREA NOT BEING CLEANED BEFORE STARTING PD. DIANEAL THERAPY WAS ONGOING. MEDICAL HISTORY INCLUDED END STAGE RENAL DISEASE (ESRD), HYPERTENSION, DIABETES, HEART DISEASE AND BEING BED-RIDDEN LAST 3 YEARS DUE TO PELVIC JOINT FRACTURE. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE REPORTER BELIEVED THE EVENT OF PERITONITIS WAS NOT RELATED TO DIANEAL THERAPY. THE REPORTER DID NOT COMMENT ON CAUSALITY FOR THE EVENT OF AREA NOT CLEAN BEFORE STARTING PD. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention DIANEAL PD2 ULTRABAG