BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1871772 · Received October 15, 2010

    Report

    Report Number
    1423500-2010-04464
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 21, 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). PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT (HP) REGARDING THE REPORTED PROBLEM. THE HP STATED THEY WERE ABLE TO RESUME WITH THERAPY BY STARTING WITH NEW SUPPLIES. NO DEFECTS WERE NOTED AT THE TIME AND THERE WERE NO SAMPLES OR LOT NUMBER TO PROVIDE. THE HP IS RESUMING THERAPY ON THE CYCLER. THERE WAS NO MEDICAL INTERVENTION OR PATIENT INJURY.

    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 CHECK LINES AND BAGS ALARM. THE REPORTED CONDITION WAS NOT CONFIRMED DUE TO LACK OF PRODUCT SAMPLE. A BATCH REVIEW WAS NOT PERFORMED BECAUSE LOT INFORMATION WAS UNKNOWN. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE INCIDENT WAS NOT DETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES REGARDING A CHECK LINES AND BAG ALARM THAT OCCURRED ON THE HOMECHOICE UNIT DURING SET UP. THE HP STATED SHE WAS NOT CONNECTED AND CHANGED OUT ONE OF THE BAGS DURING THE SETUP. THE TECHNICAL SERVICE REPRESENTATIVE ADVISED THE HP TO RESTART THE SETUP WITH ALL NEW SUPPLIES DUE TO A POSSIBLE COMPROMISE OF STERILITY. THE HP STATED THAT SHE DID NOT WANT TO RESTART THE SETUP WITH NEW SUPPLIES AND WOULD JUST TURN OFF THE MACHINE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS 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 50 YR