BEUDAMED
    FDA Adverse Event Death Summary report: N

    SERAPH 100

    MDR report key: 13141717 · Received December 30, 2021

    Report

    Report Number
    MW5106397
    Event Type
    Death
    Date Received
    December 30, 2021
    Date of Event
    December 17, 2021
    Report Date
    December 29, 2021
    Manufacturer
    EXTHERA MEDICAL CORPORATION
    Product Code
    FLD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SERAPH 100 USE FOR COVID-19 UNDER EMERGENCY USE AUTHORIZATION (EUA): DIAGNOSED WITH COVID-19 AND ACUTE HYPOXIC RESPIRATORY FAILURE WITH A HISTORY OF ESRD ON HD. SHE WAS ADMITTED ON (B)(6) 2021 AND STARTED WITH INITIAL HD ON (B)(6) 2021. AFTER WORSENING RESPIRATORY FAILURE NOTED, SHE WAS THOUGHT TO BE A CANDIDATE FOR SERAPH 100 USE ON (B)(6) 2021. PATIENT WAS STARTED ON HD WITH ADDITION OF HEMOFILTRATION DEVICE SERAPH 100 ON (B)(6) 2021. SHE WAS ALSO ANTICOAGULATED WITH A HEPARIN DRIP PER EUA PROTOCOL BUT DEVELOPED SIGNIFICANT BLEEDING AT AV FISTULA SITE REQUIRING BLOOD TRANSFUSION AND PROTAMINE SULFATE USE. SHE HAD A SECOND ROUND OF SERAPH 100 ON (B)(6) 2021 WITHOUT COMPLICATION. SHE DEVELOPED WORSENING RESPIRATORY FAILURE WHICH REQUIRED MECHANICAL VENTILATION ON (B)(6) 2021. SHE DEVELOPED WORSENING SHOCK WITH SUSPICION OF MESENTERIC ISCHEMIA AND BOWEL INFARCTION. SHE DEVELOPED CARDIAC ARREST WITH CPR BUT EXPIRED ON (B)(6) 2021. FDA SAFETY REPORT ID#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2021483 SERAPH 100 APPARATUS, HEMOPERFUSION, SORBENT FLD EXTHERA MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Death