BEUDAMED
    FDA Adverse Event Death Summary report: N

    CL BLOOD SET Y-TYPELARGE 170-260 FILTER HAND PUMP

    MDR report key: 1873343 · Received October 19, 2010

    Report

    Report Number
    6000001-2010-04240
    Event Type
    Death
    Date Received
    October 19, 2010
    Date of Event
    September 26, 2010
    Report Date
    October 1, 2010
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    BRZ
    PMA / PMN Number
    K003225
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED, THEREFORE, NO EVALUATION WAS PERFORMED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED THEREFORE NO EVALUATION WAS PERFORMED. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED. THE ROOT CAUSE OF THIS INCIDENT WAS UNDETERMINED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE BAXTER INTRAVENOUS (IV) THERAPY REPRESENTATVIE INDICATED A NURSE EDUCATOR REPORTED A Y-TYPE BLOOD/SOLUTION SET WAS INVOLVED WITH A MALE PATIENT'S DEATH. THIS PAST WEEKEND THE ASSISTANT HEAD NURSE OF THE ICU (INTENSIVE CARE UNIT) ADVISED THE HAND BLOOD PUMP SET WAS BEING USED ON A MALE PATIENT WHO WAS BLEEDING OUT THROUGH THE ARTERIAL LINE. REPORTEDLY, THE BLOOD PUMP WAS NOT FLOWING FAST ENOUGH OR QUICK ENOUGH TO ADMINISTER BLOOD AND THE PATIENT EXPIRED. THE CAUSE OF DEATH IS UNKNOWN. THE PUMP TUBING IS LISTED AS THE POTENTIAL ISSUE THAT CAUSED THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CL BLOOD SET Y-TYPELARGE 170-260 FILTER HAND PUMP SET, BLOOD TRANSFUSION BRZ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H