BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1880450 · Received October 22, 2010

    Report

    Report Number
    1423500-2010-04819
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    October 3, 2010
    Report Date
    October 5, 2010
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS RECEIVED SIMILAR REPORTS AND WILL CONTINUE TO MONITOR THESE REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT CODE IS UNKNOWN AND THEREFORE THE 510(K) ENTRY FIELD HAS BEEN LEFT BLANK. AS THE PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRECTOMY PROCEDURE, WHEN THE DEVICE WAS FIRED ON THE BLOOD VESSEL, THE SECOND AND THE THIRD CLIPS WERE FORMED AS TEARDROP-SHAPED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Description of Event or Problem · 1

    EMAIL RECEIVED IN CORPORATE MAILBOX ON (B)(6) 2010. NURSE REPORTED THE PATIENT (HP) WENT TO THE EMERGENCY ROOM WITH COMPLAINT OF ABDOMINAL PAIN. UPON ADMISSION TO THE HOSPITAL, THE PATIENT WAS STARTED ON IV ANTIBIOTICS. THE PATIENT WAS DIAGNOSED WITH PERITONITIS AND THERE WAS NO EXIT SITE INFECTION.

    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 Hospitalization| R