BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM COMBI SET

    MDR report key: 3190369 · Received June 21, 2013

    Report

    Report Number
    8030665-2013-00388
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 24, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FJK
    PMA / PMN Number
    K962081
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFO AND RETURN OF THE SAMPLE FOR EVAL. THIS MDR INCLUDES ALL INFO RECEIVED TO DATE. BASED ON THE INFO PROVIDED, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PT WAS REPORTED TO HAVE LOST APPROXIMATELY 500 CC OF BLOOD RESULTING IN AN ER VISIT AND STAT HEMOGLOBIN. CURRENTLY, IT IS REPORTED THE SAMPLE IS AVAILABLE FOR EVAL HOWEVER IT HAS NOT BEEN RETURNED YET. WE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN THE SAMPLE IS RECEIVED AND THE EVAL IS COMPLETE.

    Description of Event or Problem · 1

    THE CLINIC MGR REPORTED THAT BLOOD WAS NOTICED LEAKING FROM THE TUBING SET DURING TREATMENT. PER A USER SUBMITTED MEDWATCH # 1346577418-2013-0001: BLOOD LOSS GREATER THAN 500ML RESULTING IN THE PT BEING SENT TO THE ER. THE RN RESPONDED TO MACHINE ALARM FOR THE PT. ALL NEEDLE CONNECTIONS AND BLOOD LINES WERE SECURE AND TIGHT. BLOOD APPEARED TO BE COMING FROM THE TUBING LINES NEAR THE LARGEST VENOUS BLOODLINE TUBING CLAMP. ALL LINES WERE PLANED AND PUMP WAS STOPPED. PTS BLOOD PRESSURE 73/56, PULSE 117 AND REGULAR. A 400CC NS WAS GIVEN FOR BLOOD PRESSURE SUPPORT. PT DENIED DISCOMFORT. NO SAMPLE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282369 CUSTOM COMBI SET FJK FRESENIUS MEDICAL CARE NORTH AMERICA 13CR01885

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization