BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1883851 · Received October 27, 2010

    Report

    Report Number
    1423500-2010-04967
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Date of Event
    October 2, 2010
    Report Date
    October 2, 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 FOR A SYSTEM ERROR 2240 (AIR IN SET) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE CAUSE OF THE COMPLAINT WAS NOT DETERMINED. PER CAREGIVER, SHE DID NOT FIND ANY LOOSE CONNECTIONS, DISCONNECTIONS OR DEFECTS ON THE SUPPLIES. THE BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN. 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 CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN LINE) ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING DRAIN 5 OF 5. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM TO THE HOME PATIENT (HP)'S CAREGIVER (CG) AND ASSISTED WITH TROUBLESHOOTING. NO PROBLEMS WERE FOUND. THE HP DID NOT DISCONNECT DURING THERAPY. THE TSR ASSISTED TO END THERAPY AND ADVISED TO INFORM THE NURSE ABOUT THE ALARM. DURING A FOLLOW UP WITH THE CG REGARDING THE ALARM, IT WAS REVEALED THAT THE ISSUE WAS RESOLVED AND HP HAD RESUMED THERAPY, BUT ADDED THAT SHE CHECKED EVERYTHING WAS NOT ABLE TO FIND THE SOURCE OF AIR. PER CG, SHE DID NOT FIND ANY LOOSE CONNECTIONS, DISCONNECTIONS OR DEFECTS ON THE SUPPLIES. THE CG STATED THAT HP DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THIS INCIDENT. PER CG, THE HP 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 69 YR