BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARNS 8000 OCCLUSION SYSTEM

    MDR report key: 75440 · Received March 10, 1997

    Report

    Report Number
    1828100-1997-00003
    Event Type
    Malfunction
    Date Received
    March 10, 1997
    Date of Event
    February 11, 1997
    Report Date
    March 10, 1997
    Manufacturer
    3M HEALTH CARE SARNS AND CDI PRODUCTS
    Product Code
    DTQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING AN OPERATION, THE OCCLUDER DISPLAY INDICATED THAT THE OCCLUDER WAS OPEN AND BLOOD WAS FLOWING THROUGH THE TUBING. HOWEVER, THE OCCLUDER WAS ACTUALLY FULLY OBSTRUCTING THE TUBING. AS A RESULT, THERE WAS NO BLOOD FLOW TO THE PT, AND THE VENOUS RESERVOIR WAS DRAINED. NO PT INJURY HAS BEEN ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARNS 8000 OCCLUSION SYSTEM OCCLUDER DTQ 3M HEALTH CARE SARNS AND CDI PRODUCTS 98-0702-0659-8 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention