BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXTER

    MDR report key: 2233433 · Received September 2, 2011

    Report

    Report Number
    1423500-2011-11660
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 7, 2011
    Report Date
    August 10, 2011
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT WAS NOT CONFIRMED AS NO SAMPLES WERE AVAILABLE FOR EVALUATION. NO ROOT CAUSE HAS BEEN DETERMINED AND NO CORRECTIVE ACTIONS HAVE BEEN IDENTIFIED. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS INTERNATIONAL PRODUCT IS DISTRIBUTED OUTSIDE THE U.S. AND DOES NOT HAVE A 510K NUMBER, BUT IT IS BEING REPORTED AS IT IS THE SAME OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED. SAMPLE WAS NOT RETURNED; THEREFORE, NO EVALUATION COULD BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    A DOCTOR REPORTED TO BAXTER (B)(4) THAT LEAKAGE WAS FOUND ON THE CATHETER THE DAY WHEN THE TRANSFER SET WAS CHANGED TO NEW ONE. ALSO, SAME DEFECT OCCURRED 3 DAYS AFTER THAT AGAIN. THE CUSTOMER SAID THAT THE SMALL WHITE CLAMP IN THE COMPACT PREP TRAY COULD CUT THE CATHETER WHILE THE TRANSFER SET WAS CHANGED TO NEW ONE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. THERE WAS PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1