BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1956104 · Received January 10, 2011

    Report

    Report Number
    1423500-2011-00397
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 16, 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). THIS COMPLAINT WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF A SAMPLE. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT (H10I08069). A ROOT CAUSE OF THE AIR WAS NOT IDENTIFIED. 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). TWO OF 3 EMDRS. THE SAMPLE AVAILABILITY IS UNKNOWN AT THIS TIME. BAXTER IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION. A FOLLOW-UP REPORT WIL L BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER REPORTING ABOUT SEEING KINK OR AIR IN THE LINE IN THREE CASSETTES. THE HOME PATIENT (HP) DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION WAS AVAILABLE. DURING A FOLLOW UP WITH THE NURSE REGARDING AIR IN TUBINGS, THE NURSE STATED THAT SHE WAS NOT AWARE OF THE AIR IN TUBING ISSUE, BUT SUGGESTED THAT HP MAY HAVE HAD INCOMPLETE PRIMING WHICH COULD HAVE LEAD TO THE AIR IN TUBING. THE NURSE STATED THAT THE HP IS CONTINUING THERAPY. NO FURTHER INFORMATION WAS PROVIDED REGARDING THE AIR IN LINE ISSUE.

    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 H10I08069

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR HOMECHOICE CYCLER