BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1882019 · Received October 25, 2010

    Report

    Report Number
    1423500-2010-04882
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    September 30, 2010
    Report Date
    September 30, 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. THIS COMPLAINT IS FOR AIR IN LINE. THIS COMPLAINT WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. PER THE COMPLAINT INFORMATION, THERE WAS AIR IN THE PATIENT LINE. THERE WAS NOT ENOUGH DATA WITHIN THE COMPLAINT INFORMATION TO IDENTIFY ROOT CAUSE; THEREFORE THE ROOT CAUSE OF THE COMPLAINT IS NOT DETERMINED. 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). THE LOT NUMBER AND SAMPLE AVAILABILITY ARE UNKNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    DURING A FOLLOW UP WITH THE NURSE, IT WAS REVEALED THAT THE ISSUE WAS RESOLVED. THE NURSE ADDED THAT THE HOME PATIENT (HP) WAS SEEN IN THE CLINIC ON (B)(6) 2010 AND IS DOING FINE AND CONTINUING THERAPY. PER NURSE, HP DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THIS INCIDENT. 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.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING THAT SHE SAW AIR IN THE PATIENT LINE DURING WARMING SOLUTION AND WANTED ASSISTANCE TO END THERAPY ON THE HOMECHOICE (HC). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASKED THE CAREGIVER (CG) TO PRESS STOP AND ASSISTED WITH ENDING THERAPY. THE CG WOULD RESTART THE SETUP WITH ALL NEW SUPPLIES. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT.

    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 73 YR