BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1903709 · Received November 20, 2010

    Report

    Report Number
    1423500-2010-06018
    Event Type
    Malfunction
    Date Received
    November 20, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 28, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE AVAILABILITY IS UNKNOWN AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS FROM A HOME PATIENT FOR OVERPRIME. THE COMPLAINT WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE AND BATCH REVIEW WAS NOT PERFORMED SINCE LOT NUMBER INFORMATION WAS NOT AVAILABLE. 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.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING THE PATIENT LINE OVERFLOWING WHICH OCCURRED ON THE HOME CHOICE (HC), DURING PRIMING. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASKED THE HOME PATIENT (HP) IF HE PUT THE SUPPLY BAGS ON TOP OF THE HC, AND THE HP STATED NO, THEY WERE ON THE SIDE ON A TABLE. THE TSR EXPLAINED THAT THE PATIENT LINE MAY BE LOWER THAN THE HEATER BAG AND SOME SOLUTION WOULD COME OUT OF THE PATIENT LINE. THE TSR EXPLAINED THAT THE HP COULD RAISE THE PATIENT LINE IN THE ORGANIZER. THE TSR EXPLAINED THAT IF THE HC DOES NOT PRIME THE PATIENT LINE COMPLETELY, THE HP CAN REPRIME THE PATIENT LINE. THE TSR EXPLAINED THAT IF THE HP NEEDS ASSISTANCE WITH REPRIMING, THE HP CAN CALL BAXTER. THE TSR EXPLAINED THAT IF THE PATIENT LINE STILL OVERFLOWS AFTER THE PATIENT LINE IS RAISED, THE HP SHOULD CONTACT BAXTER BACK. THE HC WAS OPERATIONAL. THE SOLUTION TO THIS ISSUE WAS PROVIDED OVER THE PHONE AND A SWAP OF THE DEVICE WAS NOT NECESSARY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    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