BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1981794 · Received February 8, 2011

    Report

    Report Number
    1423500-2011-01647
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 15, 2011
    Report Date
    January 15, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S QUALITY REVIEW.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THE LOT NUMBER WAS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. BASED ON INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THE ROOT CAUSE WAS NOT DETERMINED. 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.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING A CHECK PATIENT LINE ALARM THAT OCCURRED ON THE HOMECHOICE (HC) UNIT DURING INITIAL DRAIN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP WITH TROUBLESHOOTING. THE HP STATED THAT THERE WERE LARGE GAPS OF AIR IN THE PATIENT LINE. THE TSR ADVISED THE HP TO END THERAPY AND START OVER WITH NEW SUPPLIES. THE TSR ALSO INSTRUCTED THE HP TO ENSURE THE PATIENT LINE WAS FULLY PRIMED BEFORE CONNECTING. ON (B)(4) 2011, PRODUCT SURVEILLANCE SPOKE WITH THE HP?S NURSE WHO STATED THAT THE ISSUE WAS RESOLVED; HOWEVER, THE CAUSE OF THE ALARM REMAINED UNKNOWN. THE NURSE VERIFIED THAT THERE WERE NO LOOSE CONNECTIONS, DISCONNECTIONS, OR DEFECTS NOTED WITH THE SUPPLIES. THE NURSE CONFIRMED NO ADVERSE EVENT RESULTED FROM THIS INCIDENT. THE NURSE FURTHER STATED THAT THE HP WAS CONTINUING THERAPY WITHOUT FURTHER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR HOMECHOICE PRO APD SYSTEM (B)(4)