BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYCLER DRAINAGE SET (CS=15 PR)

    MDR report key: 1880103 · Received October 22, 2010

    Report

    Report Number
    1423500-2010-04764
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 1, 2010
    Report Date
    October 1, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K791899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, NO ROOT CAUSE WAS DETERMINED. NO ISSUES WERE NOTED IN THE BATCH FILE REVIEW. 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). THIS COMPLAINT FOR A LEAKING DRAIN BAG WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE; THEREFORE, THE ASSIGNABLE CAUSE WAS NOT DETERMINED. A BATCH REVIEW WAS PERFORMED AND NO ISSUES WERE NOTED. 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). SAMPLE DISCARDED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A PATIENT CONTACTED (B)(4) ON (B)(6) 2010 TO REPORT TWO LEAKING DRAIN BAGS. THE PATIENT STATED THE BAGS WERE LEAKING AROUND THE "BIGGER BLUE PORT ON THE SIDE, WHERE YOU DRAIN IT OUT." THE PATIENT STATED THE SAMPLES HAD BEEN DISCARDED, BUT THE LOT INFORMATION WAS RETAINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYCLER DRAINAGE SET (CS=15 PR) SYSTEM, PERITONEAL, AUTOMATIC DELIVERY KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H10H05117

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR