BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1823646 · Received September 2, 2010

    Report

    Report Number
    1423500-2010-03116
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 10, 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). PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT'S NURSE FOR FURTHER INFORMATION REGARDING THE ALARM. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE PATIENT'S DIALYSIS PRODUCTS. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF A SYSTEM ERROR 2240 (AIR IN SET) ALARM. THE REPORT WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE; HOWEVER, BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THIS INCIDENT WAS DETERMINED TO BE CAUSED BY AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE SUPPLY BAG FELL AND DISCONNECTED. THE HP CONFIRMED THAT A SUPPLY BAG FELL OFF THE TABLE AND DISCONNECTED. THE BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER WAS UNKNOWN. THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE INSTRUCTS USERS TO PLACE SOLUTION BAGS ON A FLAT, STABLE SURFACE AND NOT STACKED ON TOP OF EACH OTHER. THIS REVIEW FINDS THE LABELING 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 SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES REGARDING A SYSTEM ERROR (SE) 2240 ALARM THAT OCCURRED ON THE HOMECHOICE UNIT DURING DWELL 4 OF 5. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE HP TO CLOSE THE CLAMPS AND TRANSFER SET. THE TSR EXPLAINED THE SE 2240 INDICATES A LARGE AMOUNT OF AIR HAS ENTERED SETUP. THE HP CONFIRMED THAT A SUPPLY BAG FELL OFF THE TABLE AND DISCONNECTED. THE TSR ADVISED TO REPORT THE INCIDENT TO THE PERITONEAL DIALYSIS NURSE. THE HP STATED SHE WOULD FINISH THERAPY WITH MANUAL SUPPLIES. NO FURTHER INFORMATION IS AVAILABLE.

    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