BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1813053 · Received August 24, 2010

    Report

    Report Number
    1423500-2010-02829
    Event Type
    Injury
    Date Received
    August 24, 2010
    Date of Event
    July 30, 2010
    Report Date
    August 4, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT INDICATES A SEPARATION OF THE CONNECTION BETWEEN THE PATIENT CATHETER ADAPTER AND TRANSFER SET OCCURRED DUE TO DISCONNECTION OF THE JOINT DUE TO UNKNOWN REASONS. ON PAGE 3-10 OF HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE PATIENTS ARE INSTRUCTED TO CHECK ALL DISPOSABLE SET CONNECTIONS FOR A SECURE FIT BEFORE BEGINNING THERAPY. FOR THIS REASON EXISTING PRODUCT LABELING IS JUDGED ADEQUATE FOR THE POTENTIAL USE ERROR IN THE COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE WAS NOT AVAILABLE. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. HOWEVER, IT IS KNOWN THAT THE PRODUCT IS A TRANSFER SET; THEREFORE, THE MANUFACTURING SITE INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE BLACK MARKS WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Description of Event or Problem · 1

    DURING FOLLOW-UP ON AN UNRELATED REPORT, THE FOLLOWING EVENT WAS REPORTED: THE PATIENT'S TRANSFER SET WAS SEPARATED FROM THE TITANIUM ADAPTER DURING DRAINING AND AFTER THAT, THE PATIENT RECONNECTED THEM BY HAND. THE ACTUAL SAMPLE IS NOT AVAILABLE. THIS IS A SPONTANEOUS CONSUMER REPORT WITH SUPPLEMENTAL INFORMATION BY A PHYSICIAN FROM (B)(6) OF A SEPARATION OCCURRING BETWEEN THE TRANSFER SET AND THE TITANIUM ADAPTER DURING DRAINING AND PERITONITIS IN A (B)(6) MALE PATIENT COINCIDENT WITH EXTRANEAL VIAFLEX, DIANEAL-N PD4 1.5% AND DIANEAL-N PD4 2.5% THERAPIES. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX (DOSE, FREQUENCY AND LOT # NOT REPORTED), DIANEAL-N PD4 1.5% (DOSE, FREQUENCY AND LOT # NOT REPORTED) AND DIANEAL-N PD4 2.5% (DOSE, FREQUENCY AND LOT # NOT REPORTED) INTRAPERITONEALLY (IP) FOR CHRONIC RENAL FAILURE. ON (B)(6) 2010, THE PATIENT CONTACTED BAXTER (B)(4) TECHNICAL SERVICE CENTER AND STATED THAT HE HAD BEEN HOSPITALIZED DUE TO PERITONITIS. ON (B)(6) 2010, A SEPARATION BETWEEN THE TRANSFER SET AND THE TITANIUM ADAPTER OCCURRED DURING DRAINING AND THE PATIENT RECONNECTED THEM BY HAND. ON (B)(6) 2010, THE PATIENT VISITED THE HOSPITAL FOR HEMODIALYSIS (HD) AND COMPLAINED OF ABDOMINAL PAIN. ON THAT SAME DAY, THE PATIENT WAS TREATED WITH A DOSE OF MEROPEN 0.5 MILLIGRAMS (MG) INTRAVENOUS FOR SUSPECTED PERITONITIS. THE PATIENT WAS INSTRUCTED TO PERFORM A PERITONEAL LAVAGE AT HOME. AT HOME, THE PATIENT NOTICED THE PERITONEAL EFFLUENT WAS CLOUDY. ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS AND WAS HOSPITALIZED. THE OUTCOME OF THE EVENTS WAS UNKNOWN. ACTION TAKEN WITH DIANEAL WAS NOT REPORTED. MEDICAL HISTORY WAS SIGNIFICANT FOR CHRONIC RENAL FAILURE. CONCOMITANT MEDICATIONS WERE NOT REPORTED. AT THE TIME OF THIS REPORT, EXTRANEAL AND DIANEAL THERAPIES CONTINUED UNCHANGED. THE PHYSICIAN BELIEVED THAT THE EVENT OF PERITONITIS WAS UNRELATED TO EXTRANEAL AND DIANEAL. THE PHYSICIAN CONSIDERED THAT THE EVENT OF PERITONITIS WAS CAUSED BY THE EVENT OF SEPARATION OCCURRING BETWEEN THE TRANSFER SET AND THE TITANIUM ADAPTER DURING DRAINING AND THE PATIENT RECONNECTING THEM BY HAND. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R DIANEAL-N PD4 2.5% THERAPIES| EXTRANEAL VIAFLEX, DIANEAL-N PD4 1.5%