BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1800411 · Received August 16, 2010

    Report

    Report Number
    1423500-2010-02516
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 2, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS SAMPLE IS NOT AVAILABLE FOR EVALUATION AS IT HAS BEEN DISCARDED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORT FOR A LOW DRAIN VOLUME ALARM (WITH AIR IN THE LINE) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. A BATCH REVIEW WAS PERFORMED ON THE ASSOCIATED LOT (H10E30038 ) WITH NO ISSUES NOTED. THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. THE LABELING REVIEW FOUND THAT THE LABELING WAS ADEQUATE FOR THE POTENTIAL USE ERROR IN THE REPORT. 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 BAXTER'S TECHNICAL SERVICE CENTER TO REPORT RECEIVING A LOW DRAIN VOLUME ALARM. DURING TROUBLESHOOTING, THE HOME PATIENT (HP) FOUND AIR IN THE PATIENT LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO END THERAPY, DISCARD SUPPLIES, AND START OVER WITH NEW SUPPLIES. THE TSR INFORMED THE HP THAT HE SHOULD BE CHECKING FOR AIR IN THE PATIENT LINE BEFORE HE CONNECTS TO THE MACHINE. PRODUCT SURVEILLANCE CONTACTED THE PATIENT ON (B)(4) 2010. ACCORDING TO THE PATIENT HE DID NOT SEE ANY HOLES OR LEAKS IN THE DISPOSABLES. THE PATIENT STATED HE DISCARDED HIS SUPPLIES AND RESUMED THERAPY SUCCESSFULLY. THE PATIENT'S TRANSFER SET IS STILL INTACT AND FUNCTIONING PROPERLY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR. REPORT # 3005099803-2010-04703). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO STONETOME SPHINCTEROTOMES WERE USED DURING A ENDOSCOPIC SPHINCTERECTOMY (EST) PROCEDURE. ACCORDING TO THE COMPLAINANT, WHEN ELECTRIC CURRENT WAS APPLIED TO THE FIRST DEVICE, THE CUT WIRE BROKE; NO PART FELL INTO THE PATIENT. A SECOND STONETOME SPHINCTEROTOME WAS OBTAINED AND THE CUT WIRE BROKE; NO PART FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 GOOD.

    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 H10E30038

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR