SERAPH 100
Received Aug 26, 2025 · Event occurred Sep 18, 2020
Report 3014015528-2025-00025 · MDR key 22897646
Device
Product problems
- Patient Device Interaction Problem
- Patient Device Interaction Problem
Patient
67 YR · Male
- Low Blood Pressure/ Hypotension
- Low Blood Pressure/ Hypotension
Narrative
Additional Manufacturer Narrative
COMPLAINT WAS RE-EVALUATED AS PART OF COMPLAINT REMEDIATION ACTIVITIES AND DETERMINED TO BE REPORTABLE.
Description of Event or Problem
ON (B)(6) 2020, PATIENT (MALE, 67 YEARS OLD, DIAGNOSED WITH COVID-19 ARDS) EXPERIENCED AN ACUTE BRADYCARDIC HYPOTENSIVE EVENT DURING HIS FOURTH SERAPH 100 FILTER TREATMENT. TREATMENT WAS STOPPED APPROXIMATELY 2.5HRS INTO A 5H PLANNED TREATMENT WHEN BP DROPPED FROM 131/65 AT START OF TREATMENT TO 28/23 WHEN TREATMENT WAS HALTED AND LIFE SAVING MEASURES WERE INITIATED. HYPOTENSION WAS TREATED WITH ATROPINE AND ACLS AND RESOLVED WITH SEQUALAE THE SAME DAY. PER THE DATA SHEET PROVIDED BY DDEAMC, THE PATIENT'S REPORTED HYPOTENSION WAS ALLEGED TO BE "POSSIBLY RELATED" TO THE DEVICE AS WELL AS THE PROCEDURE.