BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1792024 · Received August 10, 2010

    Report

    Report Number
    1423500-2010-02353
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 19, 2010
    Report Date
    July 19, 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). PER THE CUSTOMER, THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE OF THE CHECK PATIENT LINE ALARM WITH THE OBSERVANCE OF AIR WAS UNDETERMINED. A BATCH REVIEW WAS NOT PERFORMED AS THE LOT NUMBER WAS UNKNOWN. 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.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK PATIENT LINE ALARM, WHICH OCCURRED ON THE HOMECHOICE DURING INITIAL DRAIN. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HOME PATIENT (HP) CHECK THE LINE FOR CLOSED CLAMPS, KINKS, AIR AND FIBRIN. THE HP STATED THERE WAS A GAP OF AIR IN THE PATIENT LINE. THE TSR ADVISED THE HP TO START OVER WITH NEW SUPPLIES. PRODUCT SURVEILLANCE CONTACTED THE HP REGARDING THE REPORT OF AIR IN THE LINE. THE HP DID NOT RECALL DETAILS OF THIS EVENT, BUT STATE SHE HAS HAD NO FURTHER PROBLEMS. THE SAMPLE WAS DISCARDED AND LOT NUMBER IS UNKNOWN. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 BIOPSY FORCEPS WAS USED DURING A BIOPSY PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE A BIOPSY SAMPLE WAS RETRIEVED FROM THE STOMACH. AS THEY WERE REMOVING THE DEVICE FROM THE SCOPE IT WAS NOTED THAT THE NEEDLE WAS DEFORMED AND THE DEVICE BECAME STUCK IN THE SCOPE. THE BIOPSY FORCEPS AND SCOPE WERE REMOVED IN TANDEM FROM THE PATIENT. THE BIOPSY FORCEPS WERE CUT BY THE HANDLE AND REMOVED FROM THE SCOPE. THE PROCEDURE WAS COMPLETED WITH THIS 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 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR