BEUDAMED
    FDA Adverse Event Death Summary report: N

    CLINIMACS PLUS INSTRUMENTS

    MDR report key: 8811392 · Received July 19, 2019

    Report

    Report Number
    MW5088260
    Event Type
    Death
    Date Received
    July 19, 2019
    Date of Event
    June 17, 2019
    Report Date
    July 15, 2019
    Manufacturer
    MILTENYI BIOTEC GMBH
    Product Code
    OVG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT IS A (B)(6) Y/O MALE WITH HISTORY OF RECURRENT STAGE IV PERIPHERAL T-CELL LYMPHOMA. HE RECEIVED A TCR-ALPHA / BETA AND CD19 DEPLETED HAPLOIDENTICAL STEM CELL TRANSPLANT ON (B)(6) 2018. BRIEFLY, HE HAS BEEN ADMITTED FIVE TIMES SINCE HIS BONE MARROW TRANSPLANT FOR A NUMBER OF CARDIAC ISSUES, GRAFT-VERSUS- HOST DISEASE, MULTIPLE INFECTIONS AND RENAL FAILURE. MOST RECENTLY THIS PT WAS ADMITTED ON (B)(6) 2019 FOR WORSENING DYSPNEA ON EXERTION AND FOUND TO BE BACTEREMIC. THE PT WAS INTUBATED ON (B)(6) 2019 DUE TO PERSISTENT HYPOXIA ON CPAP. THE ETIOLOGY OF THIS WAS FELT TO BE MULTIFACTORIAL, AND LIKELY LARGELY RELATED TO PREVIOUSLY KNOWN DECOMPENSATED HEART FAILURE. REPEAT ECHOCARDIOGRAMS DURING THIS HOSPITALIZATION DID NOT REVEAL SIGNIFICANT CHANGES IN EJECTION FRACTION. THE PT RECEIVED CONTINUOUS RENAL REPLACEMENT THERAPY STARTING (B)(6). THE PT'S RESPIRATORY STATUS HAD IMPROVED ENOUGH TO BE EXTUBATED ON FRIDAY EVENING, (B)(6) 2019. HE DEVELOPED WORSENING ABDOMINAL PAIN ON (B)(6), REQUIRING INCREASED PRESSOR SUPPORT AND WAS THUS SENT FOR STAT CT ANGIO CHEST / ABDOMINAL / PELVIS THAT SUGGESTED EXTENSIVE INTESTINAL ISCHEMIA, THOUGHT TO BE MORE DUE TO HYPOPERFUSION RATHER THAN DISTAL EMBOLI. WBC COUNT ROSE AND THUS INFECTION WAS SUSPECTED. DUE TO POOR PROGNOSIS, PT WAS TRANSITIONED TO COMFORT MEASURES AND PASSED ON (B)(6) 2019. AUTOPSY WAS DISCUSSED AND NOT DESIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600177 CLINIMACS PLUS INSTRUMENTS MAGNETIC CELL SELECTION SYSTEM FOR CD 34+ CELLS OVG MILTENYI BIOTEC GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death