BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1890410 · Received November 3, 2010

    Report

    Report Number
    1423500-2010-05226
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    October 10, 2010
    Report Date
    October 10, 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). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (SE) (AIR IN SET) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE; HOWEVER, PER THE COMPLAINT INFORMATION THE CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE PATIENT DISCONNECTED THE PATIENT LINE FROM THE TRANSFER SET. THE HOME PATIENT (HP) STATED THAT SHE WAS DISCONNECTED DURING THE DWELL CYCLE AND SHE DID NOT GET BACK TO RECONNECT IN TIME, AND THE DRAIN 2 STARTED. HOWEVER, THE HP DID RECONNECT AFTER THE HC ALARMED. THE BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE POTENTIAL USE ERROR(S) IN THE COMPLAINT. 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).

    Additional Manufacturer Narrative · 1

    (B)(4). THE ISSUE WAS RESOLVED OVER THE PHONE AND WAS DETERMINED TO BE A USE ERROR; THEREFORE, A BATCH REVIEW AND SAMPLE EVALUATION IS NOT APPLICABLE FOR THIS REPORT. 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

    A CUSTOMER CONTACTED BAXTER'S (B)(4) REGARDING A SYSTEM ERROR 2240 (AIR IN LINE) ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING DRAIN 2. THE HOME PATIENT (HP) STATED THAT SHE WAS DISCONNECTED DURING THE DWELL CYCLE AND SHE DID NOT GET BACK TO RECONNECT IN TIME, AND THE DRAIN 2 STARTED. HOWEVER, THE HP DID RECONNECT AFTER THE HC ALARMED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO CLEAR THE ALARM AND ADVISED TO START OVER WITH NEW SUPPLIES. DURING A FOLLOW UP WITH THE HP REGARDING THE ALARM, IT WAS REVEALED THAT THE ISSUE WAS RESOLVED BY STARTING OVER USING NEW SUPPLIES. THE HP ADDED THAT IT WAS HER FAULT AND SHE KNOWS NOW NOT TO RECONNECT AFTER THIS ALARM. PER HP, SHE DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THIS INCIDENT. THE HP STATED THAT SHE IS DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES. 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 58 YR