BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1931634 · Received December 17, 2010

    Report

    Report Number
    1423500-2010-07001
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    September 1, 2010
    Report Date
    November 25, 2010
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED THEREFORE NO EVALUATION WAS PERFORMED. SHOULD A SAMPLE BE RECEIVED AND EVALUATED, A FOLLOW UP REPORT WILL BE SUBMITTED. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW CANNOT BE PERFORMED. AS THE PRODUCT CODE WAS NOT KNOWN, THE 510K NUMBER HAS NOT BEEN IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER WAS NOT PROVIDED, THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED. THE ROOT CAUSE OF THIS INCIDENT WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    DURING A FOLLOW UP CALL TO THE (B)(6) PATIENT ON (B)(6) 2010, THE PATIENT'S CAREGIVER (CG) FOR THE KINK IN THE PATIENT'S BAG, THE CG INDICATED THE PATIENT HAD EXPERIENCED PERITONITIS ON AN UNKNOWN DATE IN (B)(6) 2010. THE CG DID NOT REPORT THE EVENT TO BAXTER. SHE NOTICED THAT THE EFFLUENT WAS CLOUDY AND TOOK A CULTURE FOR LAB TESTING. RESULTS OF THE CULTURE ARE UNKNOWN. THE NURSES DID NOT TAKE ANOTHER CULTURE. THE PATIENT WAS STARTED ON VANCOMYCIN AND CEFTAZADIME (DOSE AND LENGTH OF THERAPY UNKNOWN). THE CG COULD NOT PROVIDE CAUSALITY OF THE EVENT. THE PATIENT RECOVERED FROM THIS FIRST EVENT OF PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention THERAPY: (B)(4) DIANEAL, PD4 1.5% 5L SYSII, (B)(4)