BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1850766 · Received October 2, 2010

    Report

    Report Number
    1423500-2010-04025
    Event Type
    Malfunction
    Date Received
    October 2, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 9, 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). PRODUCT SURVEILLANCE SPOKE WITH THE HOME PATIENT (HP) WHO STATED THAT AFTER STARTING OVER WITH NEW SUPPLIES NO FURTHER ISSUES OCCURRED. THE HP ALSO STATED THAT THEY HAVE ALREADY DISPOSED OF THE SUPPLIES AND NO FURTHER INFORMATION WAS AVAILABLE. THE HP STATED THAT THE SEPARATION OCCURRED DURING SETUP AND IT SEEMED AS IF THEY JUST SLIPPED APART. NO ADVERSE EVENT WAS REPORTED AS A RESULT OF THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE AVAILABILITY AND LOT INFORMATION ARE UNKNOWN AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THIS INCIDENT WAS DETERMINED TO BE RELATED TO THE SUPPLY BAG DISCONNECTING WITHOUT FALLING. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A BATCH REVIEW CANNOT BE CONDUCTED. 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.

    Description of Event or Problem · 1

    THE HOME PATIENT (HP) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REQUESTING ASSISTANCE TO RESTART SET UP ON THE HOMECHOICE (HC). THE HP STATED ONE OF THE BAGS CAME UN-SPIKED DURING SETUP. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO REMOVE THE OLD SET. THE HP CONFIRMED TO RESTART THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    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 60 YR