BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1760616 · Received July 19, 2010

    Report

    Report Number
    1423500-2010-01528
    Event Type
    Malfunction
    Date Received
    July 19, 2010
    Date of Event
    June 26, 2010
    Report Date
    June 26, 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). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF A SYSTEM ERROR 2240 (AIR IN SET). THE REPORT WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE; HOWEVER, 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 SUPPLY BAG FELL AND DISCONNECTED. THE HP STATED SHE HAD NO IDEA WHY THE BAG FELL; IN FACT, SHE DIDN'T REALIZE THE BAG HAD FALLEN UNTIL THE NEXT MORNING WHEN SHE CALLED INTO BAXTER. A 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 FOUND 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).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING A SYSTEM ERROR (SE) 2240 ALARM AND SE 2367 ALARM ON THE HOMECHOICE (HC) UNIT DURING FILL 2 THE PREVIOUS NIGHT. THE HOME PATIENT (HP) STATED SHE HAD TURNED OFF THE MACHINE. ON (B)(6) 2010 PRODUCT SURVEILLANCE SPOKE WITH THE HP WHO STATED SHE HAD NO IDEA WHY THE BAG FELL; IN FACT, SHE DIDN'T REALIZE THE BAG HAD FALLEN UNTIL THE NEXT MORNING WHEN SHE CALLED IN FOR TECH SUPPORT. THE HP STATED WHEN SHE INFORMED THE TSR OF THE ALARM, HE ASKED HER TO CHECK THE SET UP; THE HP THEN NOTICED THAT THE SUPPLY BAG WAS ON THE FLOOR. THE HP STATED SHE DOES USE A CXD DEVICE TO SET UP. THE HP STATED THIS WAS THE FIRST TIME A BAG HAS EVER COME UNDONE OR FALLEN. THE HP STATED AFTER ENDING THE CALL WITH THE TSR, SHE WENT TO THE CLINIC BECAUSE SHE NEEDED TO DRAIN. THE HP STATED SHE WAS THEN AT THE CLINIC A FEW MORE HOURS TO BE TREATED WITH A BAG OF ANTIBIOTICS. THE HP CONFIRMED NO INFECTION HAS RESULTED FROM THIS INCIDENT. THE HP CONFIRMED SHE HAD NO PROBLEMS WITH HER SUPPLIES. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    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 65 YR