BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1861403 · Received October 8, 2010

    Report

    Report Number
    1423500-2010-04163
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 15, 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). THIS COMPLAINT CANNOT BE CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE POTENTIAL USE ERROR IN THIS COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT TWO RT340 BREATHING CIRCUITS WERE LEAKING. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S GLOBAL TECHNICAL SERVICE CENTER TO REQUEST ENDING THERAPY ON THE HOMECHOICE (HC) DURING INITIAL DRAIN. THE NURSE (RN) STATED THE HOMEPATIENT (HP) ACCIDENTALLY STARTED INITIAL DRAIN BEFORE CONNECTING. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE RN TO END THERAPY, AND SUGGESTED THE RN HAVE THE HP START OVER WITH NEW SUPPLIES SINCE THE SUPPLIES MIGHT HAVE BEEN COMPROMISED FROM THE INITIAL DRAIN PULLING IN AIR INTO THE CASSETTE. ON (B)(6) 2010, PRODUCT SURVEILLANCE CONTACTED THE PATIENT REGARDING STARTING INITIAL DRAIN BEFORE CONNECTING. THE PATIENT STATED THAT HER SUPPLIES WERE FINE, HOWEVER, SHE DISCARDED THE SUPPLIES AND STARTED OVER WITH NEW ONES. THE PATIENT STATED IT WAS A USER ERROR. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR