BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1920501 · Received December 12, 2010

    Report

    Report Number
    1423500-2010-06813
    Event Type
    Malfunction
    Date Received
    December 12, 2010
    Date of Event
    November 21, 2010
    Report Date
    November 21, 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). THIS COMPLAINT IS FOR A REPORT OF AIR IN THE PATIENT LINE. IN A FOLLOW UP CALL BY PRODUCT SURVEILLANCE, THE PATIENT STATED THAT SHE HAD NOT PRIMED PROPERLY BEFORE STARTING THE INITIAL DRAIN. THIS COMPLAINT WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. PER THE COMPLAINT INFORMATION, THE CAUSE OF THE AIR IN TUBING IS USER ERROR - THE PATIENT CONNECTED BEFORE LINES WERE ADEQUATELY PRIMED. THIS REVIEW FOUND THE LABELING ADEQUATE FOR THE USER ERROR IN THE COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER 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 AND THE LOT NUMBER IS UNKNOWN. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REQUEST ASSISTANCE ON THE HOME CHOICE (HC) MACHINE. PER THE INITIAL REPORT, THE HOME PATIENT (HP) STATED, SHE WAS IN THE INITIAL DRAIN AND COULD SEE A GAP OF AIR IN THE PATIENT LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP WITH ENDING THERAPY SO THAT SHE COULD START OVER WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THE HOME PATIENT RETURNED THIS WRITER'S CALL. THE HOME PATIENT STATED, THERE WERE NO ISSUES WITH THE SUPPLIES, BUT THAT SHE HAD NOT PRIMED PROPERLY BEFORE STARTING THE INITIAL DRAIN. THE HOME PATIENT STATED, SHE WAS ABLE TO START OVER WITH NEW SUPPLIES AND PERFORM THERAPY WITHOUT ANY COMPLICATIONS. THE HOME PATIENT ALSO STATED, SHE DID NOT DEVELOP ANY ADVERSE REACTIONS OR NEED ANY MEDICAL INTERVENTION BECAUSE OF THE AIR IN THE LINE.

    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