BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1842425 · Received September 23, 2010

    Report

    Report Number
    1423500-2010-03646
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 1, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS NOT PERFORMED AS THE LOT NUMBER WAS UNKNOWN. THE ROOT CAUSE OF THE SYSTEM ERROR 2240 ALARM WAS UNDETERMINED. 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 ROOT CAUSE CAN NOT BE DETERMINED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A TALENT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM APPROX ONE MONTH AGO. THE AORTIC ARCH WAS NORMAL. AT THE SUBCLAVIAN ARTERY, THE DIAMETER OF THE THORACIC AORTA MEASURED 34-35 MM IN DIAMETER AND 1 CM DISTALLY IT WAS 38 MM IN DIAMETER. IT WAS REPORTED THAT WHEN DEPLOYMENT WAS INITIATED WITH THE FIRST THORACIC PROXIMAL MAIN, IT STARTED TO DEPLOY IN THE MISALIGNED POSITION, HOWEVER, THE PHYSICIAN PULLED THE DELIVERY SYSTEM DOWN AND CORRECTED THE MISALIGNED APEX. THE STENT GRAFT WAS IMPLANTED 2 CM LOWER THAN INTENDED. (MFR # 2953200-2010-02276). THE PHYSICIAN ELECTED TO IMPLANT A SECOND PROXIMAL MAIN STENT GRAFT AND DURING THE DEPLOYMENT, THE SAME THING THAT OCCURRED WITH THE FIRST DEVICE HAPPENED. A THIRD DEVICE WAS DEPLOYED AND LANDED AT THE INTENDED LOCATION. NO CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 ALARM (AIR IN LINE), WHICH WAS FOUND BY THE PERITONEAL DIALYSIS (PD) NURSE WHILE DOWNLOADING THE HOME PATIENT'S (HP) PROCARD. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE MEANING OF THE ALARM. THE TSR ADVISED THE PD NURSE TO INSTRUCT THE HP TO CALL WHEN THE ALARM OCCURS. THE SAMPLE WAS DISCARDED. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE RN. PRODUCT SURVEILLANCE CONTACTED THE PD NURSE REGARDING THE REPORTED PROBLEM. THE PD NURSE STATED SHE SPOKE TO BOTH THE PATIENT AND HIS SON AND INSTRUCTED THE PATIENT TO CALL THE BAXTER 800 NUMBER AS WELL AS THE DIALYSIS CENTER WHENEVER HE RECEIVES A SYSTEM ERROR 2240 ALARM. THE SAMPLE WAS DISCARDED AND THERE WAS NO INJURY OR MEDICAL INTERVENTION. THE HOME PATIENT IS CONTINUING THERAPY ON THE CYCLER WITH NO FURTHER ISSUES.

    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 55 YR