BEUDAMED
    FDA Adverse Event Death Summary report: N

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

    MDR report key: 1943071 · Received December 30, 2010

    Report

    Report Number
    6000001-2010-06479
    Event Type
    Death
    Date Received
    December 30, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 7, 2010
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    BRZ
    PMA / PMN Number
    K993120
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER VARIOUS DUE DILIGENCE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, NO ADDITIONAL INFORMATION HAS BEEN MADE AVAILABLE TO BAXTER. THE ROOT CAUSE IS UNDETERMINED. 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). A SAMPLE WAS NOT AVAILABLE FOR EVALUATION. A BATCH REVIEW WILL NOT BE CONDUCTED AS THE LOT IS UNKNOWN. IF ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A BAXTER IVTR (INTRAVENOUS THERAPY REPRESENTATIVE) CONTACTED CPS (CORPORATE PRODUCT SURVEILLANCE) ON (B)(6) 2012 TO COMMUNICATE A REPORT RECEIVED FROM A CUSTOMER PERTAINING TO THE DEATH OF A PATIENT INVOLVING A Y-TYPE BLOOD/SOLUTION SET WITH LARGE STANDARD BLOOD FILTER (170 TO 260 MICRON) ((B)(4)). THE CUSTOMER INDICATED THAT THE SET WAS NOT PUMPING BLOOD FAST ENOUGH, THE SET WAS CHANGED OUT BUT THE PATIENT DIED REGARDLESS. THE CUSTOMER ALSO MENTIONED THAT IT IS NOT SOLELY THE PUMP THAT CAUSED THE PATIENT'S DEATH AS THERE WERE A LOT OF OTHER FACTORS CONTRIBUTING TO THE DEATH OF THE PATIENT. THE CUSTOMER WENT ON TO SAY THE PATIENT WAS CERTAIN TO EXPIRE AND THAT THERE WAS NOTHING TO PREVENT THE PATIENT FROM DYING; IT WAS INEVITABLE. THE INCIDENT OCCURRED IN THE ICU. THE CUSTOMER ALSO MENTIONED THAT THE SLOW INFUSION OF BLOOD HAS OCCURRED TWICE OVER THE LAST 3 MONTHS. THE SAMPLE WAS DISCARDED. FOLLOW-UP INFORMATION RECEIVED ON (B)(6) 2010 IS AS FOLLOWS: PER THE BAXTER SALES REPRESENTATIVE, THE FACILITY HAS PREVIOUSLY UTILIZED A HOSPIRA BRAND OF BLOOD PUMP AND REPORTEDLY WITH USE OF THE BAXTER DEVICE HAS VERBALIZED DISSATISFACTION WITH THE PRODUCT BECAUSE THE NURSING STAFF DOES NOT FEEL THAT THEY ARE ABLE TO PUMP BLOOD QUICKLY ENOUGH. IN THIS EVENT, THE PUMP WAS USED BY A PATIENT IN THE INTENSIVE CARE UNIT (ICU) WHO WAS CRITICALLY ILL. REPORTEDLY, THE NURSING STAFF HAS ADVISED THE BAXTER SALES REPRESENTATIVE THAT THEY DO NOT FEEL THE CAUSE OF DEATH FOR THE PATIENT WAS A RESULT OF THE FLOW OF THE BLOOD PUMP. REPORTEDLY, THE PATIENT WAS CRITICALLY ILL AND SURVIVAL WAS NOT ANTICIPATED. THE CAUSE OF DEATH IS UNKNOWN. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED. IT IS UNKNOWN IF A ROOT CAUSE ANALYSIS WAS COMPLETED BY THE FACILITY. THE SALES REPRESENTATIVE WILL REQUEST CONFIRMATION IF AN ANALYSIS WAS PERFORMED AND A COPY FOR BAXTER'S REVIEW. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    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