BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1953221 · Received January 7, 2011

    Report

    Report Number
    1423500-2011-00289
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 18, 2010
    Report Date
    December 18, 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). A PRODUCT SAMPLE IS NOT AVAILABLE. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S QUALITY REVIEW.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A LOW DRAIN VOLUME ALARM (LDVA) OCCURRED DURING DRAIN 1 OF 5 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. NO ROOT CAUSE HAS BEEN IDENTIFIED. HOME PATIENT (HP) STATED THERE WAS A LOT OF AIR IN THE PATIENT LINE. 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).

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED (B)(4) REGARDING A LOW DRAIN VOLUME ALARM ON THE HOMECHOICE (HC) UNIT DURING DRAIN 1 OF 5. THE HP STATED SHE HAD DISCONNECTED IN DWELL AND DID NOT CONNECT BEFORE THE DRAIN STARTED. THE HP CONFIRMED THERE WAS AIR IN THE PATIENT LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO START OVER WITH NEW SUPPLIES. THE HP STATED SHE WAS ON VACATION AND DID NOT HAVE ANY MORE SUPPLIES. THE TSR CONFIRMED A CALL WOULD BE MADE FOR AN EMERGENCY SUPPLY ORDER FOR THE HP AND ADVISED THE HP TO WAIT FOR A CALL BACK FOR FURTHER ARRANGEMENTS. ON (B)(6) 2011, PRODUCT SURVEILLANCE FOLLOWED UP WITH THE HP VIA PHONE CALL; THE HP STATED IT TOOK A FEW HOURS, BUT SUPPLIES WERE DELIVERED TO HER HOTEL. THE HP STATED SHE RESUMED THERAPY ABOUT 5AM WHEN SHE RECEIVED HER SUPPLIES. SHE REPORTED NO ADVERSE SYMPTOMS OR INFECTION RESULTING FROM THIS EVENT. THE HP STATED THIS WAS AN ISOLATED INCIDENT AND SHE WAS CONFIDENT WITH PROPER PROCEDURES. THE HP MADE NO ALLEGATION AGAINST THE PRODUCT; THE HP CONFIRMED SHE WAS OUT OF ROUTINE PERFORMING THERAPY AND SIMPLY DID NOT GET CONNECTED BEFORE THE DRAIN RESUMED. THE HP STATED HER VACATION AND THERAPY COMPLETED WITHOUT FURTHER INCIDENT OR 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 61 YR HOMECHOICE PRO APD SYSTEM (B)(4)