BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1792028 · Received August 10, 2010

    Report

    Report Number
    1423500-2010-02360
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 18, 2010
    Report Date
    July 18, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT SURVEILLANCE SPOKE WITH THE HOME PATIENT'S (HP) NURSE (RN) WHO STATED THAT THE HP HAS HAD A CARE PLAN MEETING SINCE THE INCIDENT, AND WAS RETRAINED ON THE HOMECHOICE. THE RN ALSO STATED THAT THE PATIENT, PRIOR TO THE INCIDENT, HAD BEEN PRESCRIBED AMBIEN, WHICH WAS MAKING HIM 'OUT OF IT' AT NIGHT. SOME TIME AFTER THIS INCIDENT, THE PATIENT WAS TAKEN OFF OF THE MEDICATION. SINCE THEN, THE PATIENT HAS DONE WELL. THE RN CONFIRMED THERE WAS NO INJURY OR HARM TO THE PATIENT AS A RESULT OF THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF A SYSTEM ERROR 2240. THE REPORT WAS NOT CONFIRMED DUE TO UNAVAILABLE SAMPLE. BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE SE 2240 WAS 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 HE DISCONNECTED FROM THE PATIENT LINE. THE HP ALSO STATED HE RECONNECTED. THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE INSTRUCTS USERS HOW TO EMERGENCY DISCONNECT FOR A SHORT TIME PERIOD. THIS REVIEW FINDS THE LABELING ADEQUATE FOR THE POTENTIAL USE ERROR(S) IN THE COMPLAINT. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A BATCH REVIEW CANNOT BE COMPLETED. 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 (B)(4) REGARDING A SYSTEM ERROR (SE) 2240 ALARM THAT OCCURRED ON THE HOMECHOICE (HC) UNIT DURING THERAPY. THE HOME PATIENT (HP) STATED THAT HE DISCONNECTED FROM THE PATIENT LINE. THE HP ALSO STATED HE RECONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE SE 2240 INDICATES A LARGE AMOUNT OF AIR HAS ENTERED SETUP. THE HP ELECTED TO END THERAPY FOR THE NIGHT. THE TSR ASSISTED THE HP TO REMOVE THE CASSETTE AND TURN OFF THE HC. THE HP CONFIRMED HE WOULD CONTINUE WITH THERAPY THE NEXT NIGHT. THE TSR SUGGESTED TO INFORM THE NURSE (RN) AND TO CALL BACK WITH ANY QUESTIONS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR