BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1790734 · Received August 10, 2010

    Report

    Report Number
    1423500-2010-02334
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 19, 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). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM INDIA OF A (B)(6) FEMALE HOMECHOICE PERITONEAL DIALYSIS PATIENT. ON AN UNKNOWN DATE, A BREAK IN ASEPTIC TECHNIQUE OCCURRED. ACCORDING TO THE NURSE, THE PATIENT MADE A MISTAKE. ON (B)(6) 2010 THE PATIENT WAS DIAGNOSED WITH PERITONITIS WITH CULTURE POSITIVE FOR PSEUDOMONAS GRAM NEGATIVE ORGANISM. ON (B)(6) 2010 THE PATIENT BEGAN ANTIBIOTIC THERAPY WITH VANCOMYCIN AND AMIKACIN INTRAPERITONEAL. THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS ON (B)(6) 2010. IT WAS NOT REPORTED WHETHER THE PATIENT WAS RETRAINED IN ASEPTIC TECHNIQUE. THE PERITONITIS WAS RESOLVING. THE NURSE BELIEVED THAT THE PERITONITIS WAS NOT RELATED TO THE PERITONEAL DIALYSIS THERAPY, BUT WAS DUE TO THE BREAK IN ASEPTIC TECHNIQUE.

    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 71 Hospitalization| R DIANEAL PD2 ULTRABAG