BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1920503 · Received December 12, 2010

    Report

    Report Number
    1423500-2010-06815
    Event Type
    Malfunction
    Date Received
    December 12, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 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). THE SAMPLE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK DRAIN LINE ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC). THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HOME PATIENT (HP) INSPECT THE DRAIN LINE FOR KINKS, CLAMPS, AND TAPE. THE TSR HAD THE HP REMOVE THE TAPE AND ENSURE THE DRAIN WAS NOT SUBMERGED. THE TSR HAD THE HP DISCONNECT THE TWO 12 FOOT EXTENSIONS AND DRAIN DIRECTLY INTO THE BUCKET. THE HP WAS UNABLE TO DISCONNECT THE DRAIN LINE. THE TSR ADVISED THE HP TO END THERAPY AND CONSULT WITH THE REGISTERED NURSE (RN). THE PATIENT WOULD POSSIBLY SWITCH TO DRAIN BAGS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE CONTACTED THE PATIENT ON (B)(6) 2010. THE PATIENT STATED THE FOLLOWING: SHE SWAPPED THE HC AND THAT WAS WORKING A LOT BETTER AND THE CHECK DRAIN LINES RESOLVED. THE SAMPLES WERE DISCARDED AND THE PRODUCT CODE AND LOT NUMBERS WERE UNKNOWN. THE PATIENT STATED THE LINES ARE STUCK AND ONCE THEY ARE CONNECTED SHE IS UNABLE TO GET THEM APART. THE POINT THEY STICK IS FROM EXTENSION TO EXTENSION. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1