BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1834273 · Received September 14, 2010

    Report

    Report Number
    1423500-2010-03416
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    August 25, 2010
    Report Date
    August 25, 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 CAUSE OF THE SPIKE SEPARATING FROM THE SUPPLY BAG WAS DUE TO USE ERROR. A LABELING REVIEW WAS COMPLETED AND FOUND TO BE ADEQUATE. THE REPORTED ISSUE WAS RESOLVED OVER THE PHONE. A BATCH REVIEW WAS NOT PERFORMED AS THE LOT NUMBER WAS UNKNOWN. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER, THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOTOME RX SPHINCTEROTOME WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, GAINED ACCESS TO THE COMMON BILE DUCT WITH THE PRELOADED GUIDEWIRE. THE PHYSICIAN ATTEMPTED TO PERFORM A SPHINCTEROTOMY BUT THE DEVICE WOULD NOT BOW COMPLETELY. THE PHYSICIAN DID APPLY CURRENT BUT COULD NOT GET A PROPER CUT DUE TO THE DEVICE'S INABILITY TO BOW COMPLETELY. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER AUTOTOME RX SPHINCTEROTOME. THE DEVICE WAS REPORTED TO HAVE NO VISIBLE DAMAGE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; MELTED/SPLIT EXTRUSION.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S (B)(4) REGARDING A CHECK SUPPLY LINE ALARM, WHICH OCCURRED ON THE HOMECHOICE DURING LAST FILL. THE HOME PATIENT (HP) STATED A SUPPLY BAG BECAME UNSPIKE DURING TREATMENT AND HE REPSIKED THE BAG. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE SET-UP IS POTENTIALLY COMPROMISED AND ASSISTED WITH ENDING THERAPY. THE TSR ADVISED THE HP TO CALL THE CLINIC AND NOTIFY THE NURSE OF WHAT HAPPENED. (B)(4) SPOKE TO THE HP REGARDING THE REPORT OF THE SPIKE SEPARATING FROM THE BAG. THE HP THOUGHT HE MIGHT NOT HAVE PUSHED THE SPIKE INTO THE BAG ALL THE WAY. THE HP DID NOT REPORT ANY DEFECT OF THE SPIKE OR SUPPLY BAG. THE HP ENDED THERAPY, DISCARDED THE SET-UP AND CONTACTED THE NURSE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. THE HP WAS ADVISED TO ENSURE A PROPER CONNECTION WHEN SETTING UP FOR THERAPY. THE HP 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 64 YR