BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1963847 · Received January 19, 2011

    Report

    Report Number
    1423500-2011-00765
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    December 25, 2010
    Report Date
    December 25, 2010
    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 A SYSTEM ERROR 2240 WAS NOT CONFIRMED DUE TO THE LACK OF A SAMPLE; HOWEVER, BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THIS INCIDENT WAS DETERMINED TO BE CAUSED BY AIR BEING SUCKED INTO THE DISPOSABLE SET AFTER THE PATIENT DISCONNECTED THE PATIENT LINE FROM THE TRANSFER SET. A BATCH REVIEW WAS NOT PERFORMED AS THE LOT INFORMATION WAS UNKNOWN. THE HOMECHOICE APD SYSTEMS PATIENT AT HOME GUIDE INSTRUCTS PATIENTS ON HOW TO DISCONNECT FOR A SHORT TIME AND RECONNECT FOR EMERGENCIES. THIS REVIEW FINDS THE LABELING 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). SINCE THE PRODUCT CODE IS UNKNOWN AT THIS TIME, THERE WILL NOT BE A 510K NUMBER SUBMITTED WITH THIS REPORT.

    Description of Event or Problem · 1

    A PATIENT CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 WHILE USING THE HOMECHOICE (HC) DURING DWELL 5 OF 6. GTS EXPLAINED THE SYSTEM ERROR INDICATED A LARGE AMOUNT OF AIR HAD ENTERED INTO THE DISPOSABLE SET, AND THEY WOULD NEED TO START OVER WITH NEW SUPPLIES. THE PATIENT ELECTED TO JUST END THERAPY. GTS THEN ADVISED THE PATIENT TO NOTIFY THEIR NURSE WITHIN 24 HOURS TO LET HER KNOW WHAT HAPPENED AND INFORM HER OF ANY MISSED THERAPY. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE APD CYCLER