BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAQUET UNIVERSAL FRAME

    MDR report key: 5247422 · Received November 24, 2015

    Report

    Report Number
    8010652-2015-01007
    Event Type
    Death
    Date Received
    November 24, 2015
    Date of Event
    August 7, 2015
    Report Date
    October 30, 2015
    Manufacturer
    KEHLER STRASSE 31
    Product Code
    FWZ
    Removal / Correction Number
    8010652-08/13/2015-002-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOVEMBER 24, 2015 11:35 AM (GMT-5:00) ADDED BY (B)(6): MANY DIFFERENT PARAMETERS CONTRIBUTE TO THROMBOSIS AND TO THROMBOEMBOLIC EVENTS. FOR EXAMPLE THE FOLLOWING PARAMETERS ARE KNOWN TO HAVE AN INFLUENCE ON THROMBOEMBOLIC EVENTS IN GENERAL: DURATION OF THE SURGICAL PROCEDURE, PATIENT DISEASE, HEALTH STATUS OF THE PATIENT (CONCOMITANT MORBIDITY), PATIENT POSITIONING IN GENERAL (SUPINE POSITION AGAINST PRONE POSITION), WEIGHT AND AGE OF THE PATIENT, PROPHYLACTIC ANTITHROMBOTIC MEASURES (E.G. MEDICATION, SURGICAL STOCKING). THROMBOEMBOLIC EVENTS ARE KNOWN TO OCCUR IN ALL KINDS OF SURGERY WITHOUT ONE OR SEVERAL CLEARLY IDENTIFIED RISK FACTOR(S). THEREFORE AN INFORMED CONSENT WITHOUT MENTIONING THAT SUCH AN EVENT MAY OCCUR IS REGARDED TO BE INCOMPLETE. HOWEVER, SEVERAL TESTS WITH THE AFFECTED ADJUSTABLE POSITIONING ELEMENTS 1007.28A0 WERE PERFORMED TO DETERMINE WHETHER ALSO THE DEVICE ITSELF COULD HAVE PLAYED A ROLE. MEASURING THE VENOUS BACKFLOW BY DOPPLER SONOGRAPHY, PERFORMED BY TWO MEDICAL EXPERTS FROM OUTSIDE, OF DIFFERENT PERSONS POSITIONED ON THE ADJUSTABLE POSITIONING DEVICE REVEALED THAT THE HIP ELEMENTS NEGATIVELY AFFECT THE VENOUS BACKFLOW UNDER CERTAIN CONDITIONS AND THEREFORE MAY BE CONSIDERED AS A CONTRIBUTING FACTOR TO THROMBOEMBOLIC EVENTS.

    Description of Event or Problem · 1

    ACCORDING TO THE HOSPITAL A THROMBOEMBOLIC EVENT HAPPENED DURING A SPINE SURGERY (POSTERIOR SPINAL DECOMPRESSION) USING THE MAQUET UNIVERSAL FRAME 1007.24A0 TOGETHER WITH THE ADJUSTABLE POSITIONING ELEMENTS 1007.28A0. THE DURATION OF THE PROCEDURE WAS ABOUT 4 HOURS AND 45 MINUTES. ACCORDING TO THE HOSPITAL THE PATIENT DIED. THERE IS NO EVIDENCE AVAILABLE THAT THE DEATH WAS CAUSED BY A THROMBOEMBOLIC EVENT. THE HOSPITAL DID NOT CLAIM THAT THE DEVICE CONTRIBUTED TO THE INCIDENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778756 MAQUET UNIVERSAL FRAME ACCESSORIES, OPERATING-ROOM, TABLE (KIT) FWZ KEHLER STRASSE 31 1007.24A0

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death