BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1843187 · Received September 23, 2010

    Report

    Report Number
    1423500-2010-03674
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 31, 2010
    Report Date
    August 31, 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). 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). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF A CONNECTION ISSUE. THE REPORT WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE LOT NUMBER WAS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE CONNECTION ISSUE WAS DUE TO THE SUPPLY BAG FALLING AND DISCONNECTING. THE LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE POTENTIAL USE/USER ERROR IDENTIFIED IN THIS INCIDENT. 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). (B)(4) SPOKE WITH THE HOME PATIENT'S WIFE WHO STATED THE HP WOULD NOT BE ABLE TO PROVIDE ANY FURTHER DETAIL REGARDING THE INCIDENT. NO SAMPLES WERE AVAILABLE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. LOT INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES TO REPORT A SUPPLY BAG FELL AND DISCONNECTED ON THE HOMECHOICE (HC) MACHINE DURING THERAPY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO END THERAPY. THE HP CONFIRMED HE WOULD START OVER WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO FURTHER 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 54 YR