BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAGNETOM SPECTRA

    MDR report key: 8482548 · Received April 4, 2019

    Report

    Report Number
    3004754211-2019-64920
    Event Type
    Death
    Date Received
    April 4, 2019
    Date of Event
    January 15, 2019
    Report Date
    January 15, 2019
    Manufacturer
    SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.
    Product Code
    LNH
    PMA / PMN Number
    K153447
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2017015. (B)(4). SIEMENS IS CONDUCTING A THOROUGH INVESTIGATION OF THE REPORTED EVENTS. AS THIS EVENT IS UNDER INVESTIGATION, A ROOT CAUSE HAS NOT YET BEEN DETERMINED. A SUPPLEMENT REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. THIS EVENT OCCURRED IN (B)(6). RESUBMISSION OF INITIAL REPORT DUE TO REPORT CODE ERROR.

    Additional Manufacturer Narrative · 0

    SIEMENS HAS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. THE COMPLETE INVESTIGATION DOES NOT INDICATE A SYSTEM FAILURE OR MALFUNCTION AND NO NON-CONFORMITY WAS IDENTIFIED. THE CAUSE OF THE PATIENT DEATH WAS DUE TO COMPLICATIONS FROM CANCER AND NOT IN RELATION TO THE SIEMENS PRODUCT. THE DEATH REPORT INDICATED THAT THE PATIENT DEATH WAS THE RESULT OF "NEOPLASM". DUE TO POLAND LOCAL REGULATIONS, THE DEATH REPORT COULD NOT BE PROVIDED TO SIEMENS. REVIEW OF THE QA REPORTS BEFORE AND AFTER THE INCIDENT INDICATE THE SYSTEM WAS OPERATING WITHIN SPECIFICATION AND NO SYSTEM MALFUNCTION OCCURRED. ADDITIONALLY, SIEMENS HEALTHINEERS SHENZHEN CLINICAL EXPERTS REVIEWED THE PATIENT'S DICOM IMAGES. THE PATIENT WAS IN A VERY CRITICAL CONDITION. THE PATIENT'S PRIMARY LESION WAS VERY LARGE IN SIZE AND METASTATIC LESIONS WERE FOUND IN BOTH THE ABDOMEN AND THORAX. AS A RESULT, THE PATIENT'S DIAPHRAGM WAS MOVED UP IN SUCH A WAY THAT THE HEART AND LUNGS WERE SEVERELY PRESSED AND THE BLOOD VESSELS DISTORTED. NO FURTHER ACTIONS ARE TO BE TAKEN AS THERE IS NO NEGATIVE AWARENESS IN REGARDS TO THE QUALITY AND PERFORMANCE OF THE AFFECTED COMPONENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE MAGNETOM SPECTRA SYSTEM. DURING A PROCEDURE, A PATIENT WITH LIVER METASTASIS BEGAN TO DETERIORATE AND WENT INTO CARDIAC ARREST. THE ATTENDING PHYSICIANS PRESSED THE ERDU BUTTON AND STARTED RESUSCITATION EFFORTS. IT WAS REPORTED THAT THE PATIENT PASSED AWAY. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278758 MAGNETOM SPECTRA SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH SIEMENS SHENZHEN MAGNETIC RESONANCE LTD. 10837643

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Death