BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX PERF ASSOC SAN ANTN TX1

    MDR report key: 695361 · Received March 31, 2006

    Report

    Report Number
    1718850-2006-00004
    Event Type
    Malfunction
    Date Received
    March 31, 2006
    Date of Event
    March 3, 2006
    Report Date
    March 3, 2006
    Manufacturer
    COBE CARDIOVASCULAR, INC.
    Product Code
    DWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING SET UP, IT WAS IDENTIFIED THAT THE ARTERIAL FILTER HAD BEEN PLACED BACKWARDS IN THE CIRCUIT. THE FILTER WAS CUT OUT AT THE WYE CONNECTORS AND REORIENTED IN ORDER TO BE ABLE TO USE THE PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TX PERF ASSOC SAN ANTN TX1 CUSTOM PERFUSION PACK DWE COBE CARDIOVASCULAR, INC. NA 0601000089

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other