BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1905091 · Received November 22, 2010

    Report

    Report Number
    1423500-2010-06102
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 28, 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). PER THE CUSTOMER THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR AIR IN TUBING WITHOUT AN 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. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. THE ROOT CAUSE OF THE AIR IN LINE WAS NOT IDENTIFIED. 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.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING THAT THE PATIENT LINE IS FULL OF AIR WHILE ON THE HOMECHOICE DISPLAY DURING FILL 1. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT THE HOME PATIENT (HP) WOULD NEED TO END THERAPY AND START OVER WITH NEW SUPPLIES. THE TSR THEN WALKED THE HP THROUGH THE ENDING THERAPY EARLY PROCEDURE. THE HP ENDED THERAPY AND WOULD START OVER WITH NEW SUPPLIES. DURING FOLLOW-UP WITH THE HP REGARDING THE AIR IN LINE, IT WAS REVEALED THAT THE ISSUE WAS RESOLVED; HOWEVER HE WAS UNABLE TO FIND THE SOURCE OF AIR. PER THE HP, THERE WERE NO LOOSE CONNECTIONS, DISCONNECTIONS OR DEFECTS ON THE SUPPLIES. THE HP CONFIRMED THAT HE DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THIS INCIDENT. PER HP, HE IS DOING FINE AND CONTINUING THERAPY. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED. NO FURTHER INFORMATION WAS PROVIDED.

    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 67 YR