BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1941541 · Received December 29, 2010

    Report

    Report Number
    1423500-2010-07381
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    December 4, 2010
    Report Date
    December 8, 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). THE USED SAMPLE WAS NOT RETURNED TO BAXTER FOR EVALUATION. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. THIS REVIEW FINDS THE LABELING ADEQUATE FOR THE REPORTED USER ERROR IN THE COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S (B)(4) TO REPORT A CHECK LINES AND BAGS ALARM WHILE ON THE HOMECHOICE DEVICE DURING DRAIN 1 OF 5. THE HOMEPATIENT (HP) SAID HE HAD DISCONNECTED FROM THE MACHINE AND THE ALARM WOULD NOT CLEAR AND HE WANTED TO OPEN THE DOOR. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HELPED HIM TO END THE THERAPY AND INFORMED HIM TO START OVER USING NEW SUPPLIES. THE HOME PATIENT WAS CONTACTED ON (B)(6) 2010. THE HOME PATIENT STATED THAT THEY NOTICED THAT AFTER THE SPIKE WAS ALL THE WAY IN, IT STILL SEEMED AS IF THE BAG WAS NOT PUNCTURED ALL THE WAY. THE HOME PATIENT STATED THAT AFTER STARTING OVER WITH NEW SUPPLIES NO FURTHER ISSUES WERE FOUND. THE HOME PATIENT ALSO STATED THAT THEY HAVE ALREADY DISPOSED OF THE SUPPLIES AND NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THE HOME PATIENT ALSO STATED NO COMPANION SAMPLES WERE AVAILABLE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED 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 47 YR HOMECHOICE