BEUDAMED
    FDA Adverse Event Death Summary report: N

    H-250 SYSTEM AND DISPOSABLE

    MDR report key: 366472 · Received December 14, 2001

    Report

    Report Number
    1221261-2001-00015
    Event Type
    Death
    Date Received
    December 14, 2001
    Date of Event
    November 19, 2001
    Report Date
    December 14, 2001
    Manufacturer
    LEVEL 1, INC.
    Product Code
    BSB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LEVEL 1, INC. RECEIVED A REPORT FROM ITS DISTRIBUTOR IN AUSTRALIA, THAT A HOSPITAL REPORTED THAT DURING A TRIPLE AORTIC BYPASS PROCEDURE, THEY EXPERIECED SLOW FLOW AFTER ADMINISTERING THE THIRD OR FOURTH UNIT OF BLOOD THROUGH A LEVEL 1 DISPOSABLE IN CONJUNCTION WITH A H-250. THE PATIENT SUBSEQUENTLY DIED. HOWEVER, THE HOSPITAL HAS REPORTED TO DISTRIBUTOR THAT THE FILTER WAS PROBABLY CLOGGED, AND THAT THE SLOW FLOW RATE OF THE INFUSOR"... WAS ONLY ONE OF THE PROBLEMS THAT HAD OCCURRED." THE HOSPITAL'S NURSE MANAGER REPORTED THAT THE HOSPITAL IS NOT ATTRIBUTING THE PATIENT'S DEATH TO THE DEVICE. THE HOSPITAL REPORTEDLY PERFORMED ITS OWN TESTING AND FOUND NO PROBLEM WITH THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56609 H-250 SYSTEM AND DISPOSABLE FLUID WARMER AND DISPOSABLE BSB LEVEL 1, INC. H-250 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Death