BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2241944 · Received September 9, 2011

    Report

    Report Number
    1423500-2011-12002
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 22, 2011
    Manufacturer
    KANAE CO.,LTD.
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ISSUE WAS NOT CONFIRMED AND A ROOT CAUSE OF THIS EVENT WAS NOT IDENTIFIED. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR, BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME. PER THE CUSTOMER THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TO REPORT THAT THE PATIENT CONNECTOR WAS NOT CONNECTED TO THE TITANIUM ADAPTER TIGHTLY. THE DOCTOR THEN TRIED TO CONNECT ANOTHER TRANSFER SET TO THE TITANIUM ADAPTER, BUT THEY WERE NOT CONNECTING TIGHTLY AGAIN. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. THERE WAS PATIENT INVOLVEMENT. THIS EMDR ADDRESSES THE CONNECTION ISSUE INVOLVING THE TITANIUM ADAPTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDI KANAE CO.,LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 TRANSFER SET