BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1883777 · Received October 27, 2010

    Report

    Report Number
    1423500-2010-04960
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 4, 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). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION AS IT HAS BEEN DISCARDED, THEREFORE, BAXTER CANNOT DETERMINE THE ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT FOR A LOW DRAIN VOLUME ALARM WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE, THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. 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 CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER AND REPORTED RECEIVING A LOW DRAIN VOLUME ALARM ON THE HOMECHOICE (HC) MACHINE DURING THE INITIAL DRAIN CYCLE. THE PATIENT STATED THAT SHE HAS A LOT OF AIR IN THE PATIENT LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HOME PATIENT (HP) TO END THERAPY AND START OVER WITH NEW SUPPLIES. PRODUCT SURVEILLANCE CONTACTED THE PATIENT ON (B)(6) 2010. ACCORDING TO THE PATIENT, SHE HAS NOT HAD ANY FURTHER ISSUES SINCE THIS EVENT. THE PATIENT STATED SHE DID NOT NOTICE ANY HOLES OR LEAKS IN ANY OF HER DISPOSABLES. THE PATIENT RESUMED THERAPY SUCCESSFULLY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR