BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1890317 · Received November 3, 2010

    Report

    Report Number
    1423500-2010-05216
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    October 10, 2010
    Report Date
    October 10, 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 AIR IN THE PATIENT LINE. THE REPORT WAS NOT CONFIRMED DUE TO LACK OF PRODUCT SAMPLE. A BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER WAS UNKNOWN. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE REPORTED CONDITION WAS NOT DETERMINED. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT SAMPLE IS AVAILABLE FOR EVALUATION. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REQUEST ASSISTANCE WITH BYPASS ON THE HOME CHOICE (HC) MACHINE DURING INITIAL DRAIN. DURING TROUBLESHOOTING WITH THE TECHNICAL SERVICE REPRESENTATIVE (TSR), THE HP STATED, HE WAS USING TWO PATIENT LINE EXTENSIONS AND SAW AN AIR BUBBLE. THE TSR ADVISED THE HP TO START OVER WITH ALL NEW SUPPLIES. THE TSR ASSISTED THE HP WITH ENDING THERAPY. ON (B)(4) 2010 PRODUCT SURVEILLANCE SPOKE WITH THE HP'S NURSE WHO STATED SHE SPOKE WITH THE PATIENT THIS WEEK AND WAS NOT AWARE OF THE PATIENT HAVING PROBLEMS WITH PRIMING THE MACHINE; THE NURSE STATED, THE PATIENT DOES WELL WITH THERAPY. THE NURSE STATED, THIS PATIENT IS VERY CAREFUL AND CAUTIOUS WITH HIS SET UP. THE NURSE STATED, THE PATIENT HAS NOT ALLEGED ANY ISSUES OR DEFECTS WITH HIS THERAPY PRODUCTS. THE NURSE CONFIRMED THIS PATIENT HAS NOT REPORTED ANY ADVERSE SYMPTOMS AND INFECTIONS. ON (B)(4) 2010 PRODUCT SURVEILLANCE ALSO SPOKE WITH THE HP WHO STATED, HE WAS CAREFUL WITH HIS SET UP AND CHECKS FOR AIR EVERY TIME. THE HP CONFIRMED IF HE EVER HAS A PROBLEM, HE CALLS THE NUMBER LOCATED ON THE HC. THE HP STATED, HE WAS FEELING FINE AND THERE WAS NO INFECTION AS A RESULT OF THIS EVENT.

    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 83 YR