BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1871867 · Received October 16, 2010

    Report

    Report Number
    1423500-2010-04502
    Event Type
    Injury
    Date Received
    October 16, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 23, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR THE SUSPECT LOT NUMBERS (H10E22506, H10F24112), WITH NO DEFECTS NOTED.

    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. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE ON THE FIRST, SECOND AND THIRD FIRING THE DEVICE FIRED MALFORMED STAPLES WHICH CREATED AN INADEQUATE STAPLE LINE. THE SURGEON STATED THAT THE DEVICE DID NOT FEEL SMOOTH WHEN SHE WAS FIRING THE DEVICE. THE MALFORMED STAPLES FELL INTO THE PATIENT BUT WERE RETRIEVED. CAUTERY WAS USED TO STOP THE BLEEDING ALONG THE STAPLE LINE AND THE CASE WAS COMPLETED. NO BLOOD TRANSFUSIONS WERE GIVEN. THERE WAS NO PATIENT CONSEQUENCE.

    Description of Event or Problem · 1

    ON AN UNREPORTED DATE, THE PATIENT BEGAN PERITONEAL DIALYSIS (PD) TREATMENT. DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE PATIENT'S NURSE REPORTED THE FOLLOWING INFORMATION. ON (B)(6) 2010, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED. THE CAUSE OF PERITONITIS WAS UNKNOWN. A PERITONEAL EFFLUENT CULTURE WAS PERFORMED, AND THE RESULTS WERE REPORTED AS UNKNOWN. IT WAS UNREPORTED WHETHER TREATMENT WAS PROVIDED. PD THERAPY WAS REPORTED AS ONGOING. ON (B)(6) 2010 THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE NURSE REPORTED THAT THE PATIENT WAS RECOVERING FROM THE EVENT OF PERITONITIS. CONCOMITANT MEDICATIONS WERE NOT REPORTED. PER THE NURSE, THE EVENT OF PERITONITIS WAS UNRELATED TO PD THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R