BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1821860 · Received August 31, 2010

    Report

    Report Number
    1423500-2010-03026
    Event Type
    Malfunction
    Date Received
    August 31, 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 SPOKE TO THE HOME PATIENT (HP) REGARDING THE PATIENT LINE OVERPRIMING. THE HP STATED HE BELIEVED THE CAUSE WAS DUE TO A CLOSED CLAMP ON A SUPPLY LINE. THE SET-UP WAS DISCARDED AND LOT NUMBER WAS UNKNOWN. THE HP IS CONTINUING THERAPY AS USUAL WITH NO ISSUES. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE OF THE OVERPRIME 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.

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE AVAILABILITY IS UNKNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED IF A SAMPLE OR ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    NOTE: THIS EVENT, AS REPORTED, DID NOT REFLECT AN MDR REPORTABLE SCENARIO; HOWEVER, EVALUATION OF THE RETURNED DEVICE REVEALED AN MDR REPORTABLE MALFUNCTION. THIS MANUFACTURER REPORT IS BEING SUBMITTED BASED ON THE EVALUATION RESULTS. NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE FIRST OF THREE DEVICES USED IN THE SAME PROCEDURE. REFER TO THE ASSOCIATED MANUFACTURER REPORT NUMBER 3005099803-2011-00044 FOR A DESCRIPTION OF THE SECOND DEVICE, AND MANUFACTURER REPORT NUMBER 3005099803-2011-00045 FOR A DESCRIPTION OF THE THIRD DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2010 THAT A GRASPIT UROLOGICAL GRASPING FORCEPS WAS USED IN A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE PERFORMED ON (B)(6) 2010 (PATIENT ID, AGE, GENDER, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, WHEN THEY ENGAGED THE STONE AND ATTEMPTED TO REMOVE IT, ONE SIDE OF THE GRASPIT JAW BROKE. NO PART OF THE JAW COMPLETELY DETACHED FROM THE DEVICE, AND NOTHING HAD TO BE RETRIEVED FROM THE PATIENT. THE STONE FELL OUT OF THE FORCEPS AND THE GRASPIT WAS REMOVED FROM THE PATIENT WITHOUT COMPLICATIONS. THE SIZE OF THE STONE WAS UNKNOWN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT, UNKNOWN DEVICE. 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 "FINE".

    Description of Event or Problem · 1

    A SYSTEM ERROR (SE) 2240 ALARM WAS IDENTIFIED IN THE LOGS DURING THE EVALUATION OF A HOMECHOICE DEVICE. THE SYSTEM ERROR OCCURRED ON (B)(6) 2010. A SE 2240 (AIR IN SET) IS A NON-RECOVERABLE ALARM THAT OCCURS WHEN THE DEVICE HAS DETECTED AIR BEING DRAWN CONTINUOUSLY INTO THE DISPOSABLE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM THERAPY QUESTIONS ON THE HOMECHOICE (HC) DURING INITIAL DRAIN. THE HOME PATIENT (HP) STATED HE SAW SOME SOLUTION RUN OVER THE TOP OF THE LINE BEFORE HE CONNECTED. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE EXPLAINED TO THE HP THE PATIENT LINE IS OKAY AND FULLY PRIMED. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED AT THE TIME OF THE INITIAL REPORT.

    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 51 YR