BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTUS 3000

    MDR report key: 3650489 · Received January 7, 2014

    Report

    Report Number
    2518443-2013-00001
    Event Type
    Malfunction
    Date Received
    January 7, 2014
    Date of Event
    December 11, 2013
    Report Date
    January 6, 2014
    Manufacturer
    CAPINTEC, INC.
    Product Code
    IZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NUCLEAR MEDICINE TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    HISTORY OF THE SYSTEM INVOLVED IN THE COMPLAINT. ON (B)(6) 2011, THE SYSTEM WAS UPGRADED AT THE CUSTOMER'S REQUEST TO A CAPTUS 3000 (CNV 712). BECAUSE THE SYSTEM WAS MORE THAN 10 YEARS OLD, THE UPGRADE INCLUDED A NEW COLLIMATOR RECEPTACLE, CAPTIVE SPRING PLUNGER AND SNAP RING, WHICH TOGETHER SUPPORT THE COLLIMATOR. ALL OF THESE COMPONENTS WERE INSTALLED BY THE CUSTOMER'S BIOMEDICAL ENGINEERING DEPARTMENT. ON (B)(6) 2012, CUSTOMER PURCHASED ANOTHER COLLIMATOR RECEPTACLE, CAPTIVE SPRING PLUNGER AND SNAP RING, AS WELL AS TWO KINDS LOCATED ON THE COLLIMATOR RECEPTACLE. ON (B)(6) 2012, CUSTOMER PURCHASED TWO KNOBS LOCATED ON THE SPRING ARM. ON (B)(6) 2013, SOMEONE FROM THE CUSTOMER'S BIOMEDICAL ENGINEERING DEPARTMENT CALLED STATING UNIT INDICATED WEAR. AT THAT TIME, CUSTOMER ORDERED ANOTHER COLLIMATOR, COLLIMATOR RECEPTACLE, AND CAPTIVE SPRING PLUNGER. ON (B)(6) 2013, CUSTOMER ORDERED ANOTHER FOUR PLASTIC KNOBS. ON (B)(6) 2013, CUSTOMER ORDERED DETECTOR SIGNAL CABLE. ON (B)(6) 2013, (B)(4), CUSTOMER'S CHIEF TECHNOLOGIST, CALLED TO REPORT THE ABOVE INCIDENT. NOTE: CAPINTEC HAS REQUESTED RETURN OF SUSPECT DEVICE ON MULTIPLE OCCASIONS, BUT HAS NOT YET RECEIVED IT. THEREFORE, COMPLETE EVAL AND FAILURE ANALYSIS CANNOT BE PERFORMED UNLESS/UNTIL THE DEVICE IS RETURNED.

    Description of Event or Problem · 1

    TECHNOLOGIST REPORTED THAT SHE WAS POSITIONING THE COLLIMATOR, WHICH HOUSES THE DETECTOR OF THE CAPTUS 3000, OVER THE PT'S LEG TO PERFORM A MEASUREMENT. THE COLLIMATOR DETACHED FROM THE ARM, AND HIT THE PT NEAR THE KNEE AREA. THE SIGNAL, CABLE REMAINED ATTACHED. THE PT EXPERIENCED SWELLING, WAS TREATED WITH ICE AN SENT TO THE ED FOR EVAL. X-RAYS WERE NEGATIVE FOR FRACTURE, AND THE PT WAS SENT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10335 CAPTUS 3000 THYROID UPTAKE SYSTEM IZD CAPINTEC, INC. CAPTUS 3000

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR