BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1894294 · Received November 9, 2010

    Report

    Report Number
    1423500-2010-05525
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 18, 2010
    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). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF A SYSTEM ERROR 2240 (AIR IN SET). THE REPORTED CONDITION WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THE ROOT CAUSE WAS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE SUPPLY BAG FELL AND DISCONNECTED. THE CUSTOMER STATED THE SUPPLY BAG FELL AND DISCONNECTED. A BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER WAS UNKNOWN. 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). THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES REGARDING A SYSTEM ERROR 2240 ALARM THAT APPEARED ON THE HOMECHOICE (HC) UNIT DURING USE. THE HP STATED THE SUPPLY BAG FELL AND DISCONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO REPLACE DISPOSABLES AND EITHER START OVER WITH NEW DISPOSABLES OR PERFORM CONTINUOUS AMBULATORY PERITONEAL DIALYSIS. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE HP. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) THAT A SPIKE OF THE Y- SET SPIKED THE OUTSIDE OF SPIKE PORT. THE CUSTOMER REPORTED NO ALARM. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION.

    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 72 YR