BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1984296 · Received February 10, 2011

    Report

    Report Number
    1423500-2011-01754
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    October 17, 2010
    Report Date
    October 17, 2010
    Manufacturer
    UNKNOWN MANUFACTURING FACILITY
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR THE SE 2240 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE; THEREFORE, THE ASSIGNABLE CAUSE WAS NOT DETERMINED. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. THE PATIENT DID NOT CHECK TO SEE IF THE LINE EXTENSIONS WERE FULLY PRIMED. THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE PROVIDES INSTRUCTIONS ON NOT CONNECTING UNLESS SET IS PRIMED COMPLETELY. A LABELING REVIEW WAS PERFORMED AND FOUND THE LABELING ADEQUATE FOR THE POTENTIAL USE ERROR(S) IN THIS COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA-(B)(4). THIS REPORT WILL BE TREATED AS AN ALLEGATION AGAINST THE CASSETTE; HOWEVER, SINCE THE PRODUCT CODE IS UNKNOWN, THERE WILL NOT BE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT OF A SYSTEM ERROR 2240 THAT OCCURRED ON A HOMECHOICE (HC) CYCLER DURING THE INITIAL DRAIN. THE PATIENT WAS CONNECTED AT THE TIME OF THE ERROR AND DID NOT DISCONNECT AT ANY TIME PRIOR TO THE EVENT. ALL OF THE BAGS WERE PROPERLY SPIKED AND CONNECTED. PATIENT EXTENSION LINES WERE USED, HOWEVER, THE PATIENT DID NOT VERIFY IF THE LINE WAS PRIMED PRIOR TO CONNECTING TO START THERAPY. THE PATIENT ELECTED TO START OVER WITH NEW SUPPLIES AND WOULD NOTIFY HIS DIALYSIS NURSE. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE APD CYCLER R5C8320