BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1896806 · Received November 11, 2010

    Report

    Report Number
    1423500-2010-05578
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 17, 2010
    Report Date
    October 17, 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). ADDITIONAL INFORMATION RECEIVED FROM THE NURSE. THIS REPORT FOR AIR IN THE PATIENT LINE WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. PER THE COMPLAINT INFORMATION, THE CAUSE OF THE AIR IN TUBING IS USER ERROR. LABELING REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THE COMPLAINT. 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 LOT NUMBER AND SAMPLE AVAILABILITY ARE UNKNOWN AT THIS TIME. BAXTER IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BAXTER PRODUCT SURVEILLANCE CONTACTED THE NURSE ON (B)(6) 2010. ACCORDING TO THE NURSE SHE WAS NOT AWARE OF THIS EVENT, HOWEVER, STATED THAT THE PATIENT IS STILL ON PERITONEAL DIALYSIS THERAPY AND HAS NOT REPORTED HAVING ANY ISSUES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICES AND REPORTED THAT THE LINE WAS FILLED WITH AIR WHEN THE HOMECHOICE MACHINE WAS AT THE CHECK PATIENT LINE/CONNECT YOURSELF DISPLAY PRIOR TO THE START OF THERAPY. THE HOME PATIENT (HP) WOKE UP IN THE MIDDLE OF THE NIGHT AND THE HC READ 'CONNECT YOURSELF' AND THE LINE WAS FILLED WITH AIR. THERE WAS NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR