BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1833993 · Received September 14, 2010

    Report

    Report Number
    1423500-2010-03398
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    August 22, 2010
    Report Date
    August 22, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF A LOW DRAIN VOLUME ALARM. THE 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 UPON THE INFORMATION OBTAINED DURING BAXTER?S INVESTIGATION, THE ROOT CAUSE OF THE ALARM WAS FROM AIR IN THE PATIENT LINE; HOWEVER, THE CAUSE OF THE AIR IS UNDETERMINED. 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 (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE AVAILABILITY AND LOT INFORMATION ARE UNKNOWN AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES REGARDING A LOW DRAIN VOLUME ALARM ON THE HOMECHOICE (HC) UNIT DURING INITIAL DRAIN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE HP WITH TROUBLESHOOTING. THE HP STATED THAT AIR BUBBLES WERE IN THE PATIENT LINE. THE TSR ADVISED THE HP TO END THERAPY AND START OVER WITH NEW SUPPLIES. THE TSR THEN ADVISED THE HP OF THE IMPORTANCE OF MAKING SURE THE PATIENT LINE IS FULLY PRIMED BEFORE CONNECTING. THE HP CONFIRMED HE UNDERSTOOD EXPLANATION AND WOULD START OVER WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 112 MG/DL ON COMPACT PLUS SYSTEM AND 269 MG/DL ON ADVANTAGE SYSTEM WITHIN 10 MINUTES. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE METERS AND STRIPS.

    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 60 YR