BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1823443 · Received September 2, 2010

    Report

    Report Number
    1423500-2010-03100
    Event Type
    Injury
    Date Received
    September 2, 2010
    Date of Event
    July 1, 2010
    Report Date
    August 11, 2010
    Manufacturer
    UNKNOWN MANUFACTURING FACILITY
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). -ROOT CAUSE FOR THE PERITONITIS WAS NOT IDENTIFIED DUE TO LACK OF SAMPLE FOR EVALUATION AND INSUFFICIENT INFORMATION AVAILABLE. SINCE THE LOT NUMBER IS UNKNOWN A BATCH REVIEW COULD NOT BE PERFORMED. NO SPECIFIC PRODUCT FAILURES WERE INDICATED IN THE COMPLAINT REPORT THAT COULD CONTRIBUTE TO PERITONITIS. BAXTER HAS RECEIVED SIMILAR REPORTS AND WILL CONTINUE TO MONITOR THESE REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(6) REGARDING PERITONITIS IN A (B)(6) MALE HOMECHOICE PERITONEAL DIALYSIS (PD) PATIENT. THE PATIENT'S WIFE CONTACT BAXTER (B)(4) TECHNICAL SERVICE CENTER TO REPORT THAT THE PATIENT WAS IN THE HOSPITAL FOR PERITONITIS. UPON FOLLOW-UP, THE NURSE REPORTED THAT ON AN UNREPORTED DATE IN 2010, THE PATIENT DEVELOPED PERITONITIS, MANIFESTED BY CLOUDY EFFLUENT, ABDOMINAL PAIN AND PYREXIA. ON (B)(6) 2010, THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. THE NURSE REPORTED THAT THE CAUSATIVE MICROORGANISM WAS UNKNOWN. INFORMATION REGARDING RELEVANT LABORATORY TESTING WAS UNKNOWN. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON AN UNREPORTED DATE IN 2010, THE EVENTS OF PERITONITIS RESOLVED. THE ROOT CAUSE OF THE PERITONITIS WAS NOT REPORTED. THE PATIENT'S MEDICAL HISTORY INCLUDED RENAL FAILURE CHRONIC AND APHASIA. THE NURSE BELIEVED THAT THE EVENTS OF PERITONITIS AND PYREXIA WERE UNRELATED 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 70 YR Hospitalization| R DIANEAL PD2 UNKNOWN BAG