BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERATOR 45

    MDR report key: 5427310 · Received February 3, 2016

    Report

    Report Number
    3004972304-2016-00005
    Event Type
    Malfunction
    Date Received
    February 3, 2016
    Report Date
    May 17, 2016
    Manufacturer
    CAIRE INC.
    Product Code
    BYJ
    PMA / PMN Number
    K800742
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY THE QDV WAS RETURNED TO THE COMPANY FOR NON-DESTRUCTIVE TESTING. THE QDV WAS BROKEN INTO TWO PIECES. THE BROKEN SECTION OF THE QDV WAS MEASURED AND THE ID AND OD WERE FOUND TO BE WITHIN SPECIFICATIONS. THE BROKEN QDV IS CONSISTENT WITH AN EXCESSIVE CANTILEVER LOAD LAVING BEEN APPLIED TO THE TOP SECTION OF THE PART. THE MOST LIKELY CAUSE OF THE FAILURE WAS AN EXCESSIVE BENDING FORCE APPLIED BY THE "FILLING STICK", WHICH IS ASSUMED TO BE THE MATING PORTION OF THE QDV WHICH IS CONNECTED TO THE LOX TRANSFER HOSE.

    Additional Manufacturer Narrative · 1

    WE ARE ATTEMPTING TO HAVE THE UNIT RETURNED FOR EVALUATION. AFTER TESTING HAS BEEN COMPLETED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE COMPANY WAS NOTIFIED ON (B)(6) 2016 OF AN INCIDENT INVOLVING A HOME CARE PROVIDER TECHNICIAN. THE DATE OF THE INCIDENT IS UNKNOWN. THE INCIDENT WAS DESCRIBED AS FOLLOWS: THE "TECHNICIAN, IN HIS CAR, WAS FILLING HIS 45L UNIT, LINKED TO HIS 20000L CISTERN BEFORE HE LEFT ON TOUR. WHEN IT WAS FULL HE REMOVED THE FILLING STICK. AT THIS POINT A LARGE VIOLENT JET OF LIQUID OXYGEN CAME FROM THE TANK CONNECTOR. NARROWLY AVOIDING THE PROJECTION OF LIQUID OXYGEN, THE TECHNICIAN HASTILY MOVED TO THE OUTSIDE OF THE CARE, WHEN THE UNIT WAS EMPTY HE NOTICED THAT A PART OF THE CONNECTOR TO THE DEWAR WAS STUCK TO THE STICK, THE LATTER HAVING COLLAPSED." THERE WAS NO INJURY TO THE TECHNICIAN.

    Description of Event or Problem · 1

    THE COMPANY WAS NOTIFIED ON JANUARY 8, 2016 OF AN INCIDENT INVOLVING A HOME CARE PROVIDER TECHNICIAN. THE DATE OF THE INCIDENT IS UNKNOWN. THE INCIDENT WAS DESCRIBED AS FOLLOWS: THE "TECHNICIAN, IN HIS CAR, WAS FILLING HIS 45L UNIT, LINKED TO HIS 20000L CISTERN BEFORE HE LEFT ON TOUR. WHEN IT WAS FULL HE REMOVED THE FILLING STICK. AT THIS POINT A LARGE VIOLENT JET OF LIQUID OXYGEN CAME FROM THE TANK CONNECTOR. NARROWLY AVOIDING THE PROJECTION OF LIQUID OXYGENT, THE TECHNICIAN HASTILY MOVED TO THE OUTSIDE OF THE CARE, WHEN THE UNIT WAS EMPTY HE NOTICED THAT A PART OF THE CONNECTOR TO THE DEWAR WAS STUCK TO THE STICK, THE LATTER HAVING COLLAPSED." THERE WAS NO INJURY TO THE TECHNICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66875 LIBERATOR 45 UNIT, LIQUID OXYGEN, STATIONARY BYJ CAIRE INC. LIBERATOR 45

    Patients

    Seq Age Sex Outcome Treatment
    1 Other