SERAPH 100 MICROBIND AFFINITY BLOOD FILTER

Additional Manufacturer Narrative

REPORTING DELAYED DUE TO NEED TO CREATE AN ACCOUNT FOR REPORTING THROUGH WEBTRADER/ESG. MANUFACTURER FEI CODE WAS NOT IN TEST SYSTEM, SO ADDITIONAL ACTIONS WERE REQUIRED BEHIND THE SCENE BY FDA REPRESENTATIVES IN ORDER FOR TEST SUBMISSION TO CDRH TO BE SUCCESSFUL.

Description of Event or Problem

PATIENT (B)(6) IS A (B)(6)-YEAR-OLD FEMALE, WITH NO SIGNIFICANT MEDICAL HISTORY, WHO FIRST TESTED POSITIVE FOR SARS-COV-2 ON (B)(6) 2021 VIA A NASAL SWAB PCR. SHE WAS ADMITTED TO THE HOSPITAL, DIRECTLY TO THE ICU, ON (B)(6) 2021 FOR PNEUMONIA. AS PART OF HER COVID-19 TREATMENT, SHE RECEIVED REDEMSIVIR, AZITHROMYCIN, AND CEFTRIAXONE. SHE CONTINUED TO REQUIRE ICU LEVEL CARE, AND HER CLINICIANS DECIDED TO USE THE SERAPH-100® FOR HER EARLY ARDS AS WELL AS SEVERE AND LIFE-THREATENING DISEASE, AS DEFINED IN THE EUA. HER CLINICIANS ORDERED FOR A 48-HOUR TREATMENT COURSE, CONSISTING OF TWO FILTERS TO RUN FOR 24 HOURS EACH. NO CONCURRENT EXTRACORPOREAL THERAPIES WERE PROVIDED. HEPARIN WAS STARTED PRIOR TO THE FIRST FILTER, WITH 25,000 UNITS AT 03:33 ON (B)(6) AND A DRIP OF 12 UNITS/KG/HR. THE FIRST SERAPH-100® FILTER STARTED (B)(6) 2021 AT 13:00 AND WAS DISCONTINUED (B)(6) 2021 AT 13:00. A SECOND FILTER WAS STARTED IMMEDIATELY AFTER, AT 13:00 ON (B)(6) 2021. HER PLATELET COUNT WAS NOTED TO BE DECREASING ON (B)(6) AND IT CONTINUED INTO (B)(6). INITIALLY, THERE WAS CONCERN FOR HEPARIN-INDUCED THROMBOCYTOPENIA (HIT), SO HER HEPARIN DRIP WAS DISCONTINUED. HIT IS CONTRAINDICATION OF SERAPH-100® THERAPY, PER THE EUA IFU. AS A RESULT, THE SECOND FILTER WAS DISCONTINUED EARLY, ON (B)(6) 2021 AT 04:44. THE SITE REPORTED THIS EVENT AS THROMBOCYTOPENIA - EXPECTED YET SERIOUS, AND POSSIBLY RELATED TO BOTH THE SERAPH-100® FILTER AND TREATMENT. NO BLEEDING OR OTHER SYMPTOMS WERE OBSERVED. THE PATIENT'S HIT ANTIBODY AND OPTICAL DENSITY (OD) LABS RETURNED NEGATIVE. HER THROMBOCYTOPENIA RESOLVED WITHOUT SEQUELAE ON (B)(6) 2021.