BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1980025 · Received February 7, 2011

    Report

    Report Number
    1423500-2011-01555
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 2011
    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 IS FOR AIR IN TUBING WITHOUT ALARM. PER THE COMPLAINT INFORMATION, THE PATIENT SAW AIR IN THE PATIENT LINE. THIS COMPLAINT WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THERE WAS NOT ENOUGH DATA WITHIN THE COMPLAINT INFORMATION TO IDENTIFY ROOT CAUSE OF THE AIR. 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). THE SAMPLE IS NOT AVAILABLE. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S QUALITY REVIEW.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING FOR A CHECK DRAIN LINE ALARM THAT APPEARED ON THE HOME CHOICE (HC) DURING THE INITIAL DRAIN, THE HOME PATIENT (HP) STATED THAT THERE WAS AIR IN THE PATIENT LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) RECOMMENDED THAT THE HP END THERAPY AND START OVER WITH NEW SUPPLIES. ON (B)(6) 2011 PRODUCT SURVEILLANCE SPOKE WITH THE HP WHO STATED THERE WERE A FEW BUBBLES IN THE LINE. THE HP CONFIRMED HE HAD NO IDEA WHAT HAPPENED TO CAUSE THEM. THE HP CONFIRMED HE SAW NOTHING UNUSUAL WITH THE SUPPLIES. THE HP FURTHER STATED HE RESUMED THERAPY WITHOUT COMPLICATIONS WITH NEW SUPPLIES. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 47 YR HOMECHOICE APD SYSTEM (B)(4) REFURBISHED