BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUIXIL APPLICATION DEVICE

    MDR report key: 1561922 · Received December 3, 2009

    Report

    Report Number
    3003183625-2009-00078
    Event Type
    Death
    Date Received
    December 3, 2009
    Date of Event
    October 20, 2009
    Report Date
    November 27, 2009
    Manufacturer
    OMRIX BIOPHARMACEUTICALS LTD.
    Product Code
    NKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY PHYSICIAN CONSIDERED THE EVENT OF FATAL AIR EMBOLISM TO BE NOT RELATED TO THE DRUG QUIXIL, AS THIS WAS NOT USED IN THE ENTIRE PROCEDURE. THIS WAS A CASE OF DEVICE MISUSE, AS THE QUIXIL DEVICE IS NOT INTENDED FOR APPLYING AIR, AND HENCE, USED OFF-LABEL. THE 35 CM TIP; MODULAR DEVICE 1, 2ML; MODULAR DEVICE 5 ML; TWO PRESSURE REGULATORS.

    Description of Event or Problem · 1

    A SERIOUS SPONTANEOUS REPORT REGARDING A MALE PT OF UNK AGE, WHO WAS REPORTED TO HAVE DIED ON AN UNK DATE. THE PT HAD RECEIVED TREATMENT WITH QUIXIL. THE CASE WAS REPORTED BY A PHYSICIAN VIA A SALES REP. NO CONCOMITANT MEDICATION OR MEDICAL HISTORY OF THE PT WAS REPORTED. THE THERAPY DATES, DOSING AND THE CLINICAL COURSE CONCERNING THE ADMINISTRATION OF QUIXIL AND THE PT'S CAUSE OF DEATH WAS NOT REPORTED. THE REPORTER STATED THAT THE PT DIED A WEEK AGO. THE REPORTER DID NOT PROVIDE A CAUSALITY ASSESSMENT. THE COMPANY PHYSICIAN ASSESSED THE CAUSALITY AS UNK. FOLLOW-UP INFO IS BEING REQUESTED FROM THE REPORTER. ON 11/18/2009, FOLLOW UP INFO WAS RECEIVED BY THE COMPANY FROM THE REPORTER. ADDITIONAL INFO WAS ALSO RECEIVED 11/20/2009, VIA A TELEPHONE CALL TO THE COMPANY FROM THE REPORTER. IN 2009, THE PT WAS UNDERGOING AN ARTHROSCOPY IN PREPARATION FOR AN AUTOLOGOUS CHONDROCYTE IMPLANTATION (ACI). THE KNEE CAVITY HAD BEEN WASHED DURING THIS PROCEDURE, AND THE TREATING SURGEON USED THE QUIXIL DEVICE TO DIRECT AIR INTO THE CAVITY TO DRY IT. ACCORDING TO THE SURGEON , AIR WAS COMING OUT OF THE KNEE DURING THE DRYING PROCEDURE. THE SURGEON STATED QUIXIL HAD NOT BEEN ADMINISTERED AND THAT HE HAD CREATED A SMALL DEFECT IN THE COLLAGEN MEMBRANE TO RECEIVE THE ACI. THE SURGEON STATED THAT IT WAS IMPORTANT THAT THE PT'S OWN BLOOD WAS PRESENT IN THE CLOT TO ENSURE THE PT'S OWN STEM CELLS WERE PRESENT TO ASSIST IN TAKING THE ACI CORRECTLY. IT WAS DURING THIS DRYING PROCEDURE, USING THE QUIXIL DEVICE, THAT THE PT DETERIORATED AND DIED. A POSTMORTEM SHOWED AIR EMBOLISM. THE SURGEON ALSO STATED THAT HE HAD BEEN PREPARED TO ADMINISTER QUIXIL IF THERE HAD BEEN BLEEDING, REQUIRING CONTROL AND WAS ALSO PLANNING TO USE QUIXIL TO HELP HOLD THE ACI IN PLACE. THE CAUSALITY OF THE EVENT OF FATAL AIR EMBOLISM WITH THE QUIXIL DEVICE WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUIXIL APPLICATION DEVICE PRESSURE REGULATOR DEVICE NKK OMRIX BIOPHARMACEUTICALS LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death