BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REN - HARDWARE

    MDR report key: 1666531 · Received April 26, 2010

    Report

    Report Number
    1423500-2010-00563
    Event Type
    Injury
    Date Received
    April 26, 2010
    Date of Event
    March 31, 2010
    Report Date
    March 31, 2010
    Manufacturer
    UNKNOWN MANUFACTURING FACILITY
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INITIAL EMDR SENT FOR THIS COMPLAINT WAS SENT IN ERROR AS PERITONITIS CANNOT BE RELATED TO A HOMECHOICE DEVICE. THE COMPLAINT WHICH ADDRESSES THE EVENT OF PERITONITIS IS NUMBER: 1423500-2010-00825.

    Additional Manufacturer Narrative · 1

    (B) (4). THE DEVICE WAS NOT RETURNED TO BAXTER FOR EVALUATION, THE SERIAL NUMBER IS UNKNOWN, AND NO EVALUATION WILL BE PERFORMED. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS IS AN INTERNATIONAL CODE FOR DISTRIBUTION OUTSIDE OF THE U.S. BUT IS BEING REPORTED AS IT IS THE SAME AS OR SIMILAR TO A CODE DISTRIBUTED WITHIN THE U.S.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THAT THE ELECTROSURGICAL UNIT (ESU/GENERATOR) WAS INVOLVED IN A PT INCIDENT. THE ESU WAS USED IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) TO ADDRESS SPHINCTER OF ODDI. THE SETTINGS WERE ENDOCUT MODE I, 2-3-2. UPON OPENING THE DUCT, A PERFORATION RESULTED (NOTE: THERE WAS AN OVERLYING FOLD.). THEREFORE, THE PT WAS ADMITTED TO THE HOSPITAL AND NON-SURGICAL MANAGEMENT WAS EMPLOYED TO ADDRESS THE PERFORATION.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CONSUMER REPORT BY A PATIENT'S FAMILY FROM (B) (6) OF DEATH AND UNSPECIFIED PERITONITIS IN AN (B) (6) MALE PATIENT COINCIDENT WITH DIANEAL-N PD-4 1.5% THERAPY. IN (B) (6) 2009, THE PATIENT BEGAN TREATMENT WITH DIANEAL-N PD-4 1.5% INTRAPERITONEALLY (IP) FOR RENAL FAILURE CHRONIC. ON (B) (6) 2010, THE PATIENT'S FAMILY CONTACTED BAXTER (B) (4) TECHNICAL SERVICE CENTER AND STATED THE PATIENT HAD EXPIRED. ON (B) (6) 2010, FOLLOW UP INFORMATION WAS MADE BY THE PATIENT'S NURSE AND THE NURSE REPORTED THAT ON (B) (6) 2010, THE PATIENT WAS HOSPITALIZED FOR UNSPECIFIED PERITONITIS. ON (B) (6) 2010, THE PD CATHETER WAS REMOVED AND PD THERAPY WAS STOPPED. ON (B) (6) 2010, DURING HOSPITALIZATION, THE PATIENT DIED. THE CAUSE OF DEATH WAS UNKNOWN, BUT WAS NOT OUTCOME OF THE PERITONITIS. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED. PER THE NURSE, THE DEATH WAS NOT RELATED TO PD THERAPY AS THE PATIENT EXPIRED AFTER THE PD THERAPY WAS WITHDRAWN. THE OUTCOME AND EVENT CAUSALITY OF UNSPECIFIED PERITONITIS WERE NOT REPORTED. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REN - HARDWARE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX UNKNOWN MANUFACTURING FACILITY

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death| R