SERAPH 100
Received Aug 26, 2025 · Event occurred Sep 21, 2021
Report 3014015528-2025-00026 · MDR key 22898959
Device
Generic name
Seraph 100
Manufacturer
Exthera Medical CorporationCatalog number
50001-EUA
Lot number
H005521
Product problems
- Patient Device Interaction Problem
- Patient Device Interaction Problem
Patient
NA · Unknown
- Low Blood Pressure/ Hypotension
- Low Blood Pressure/ Hypotension
Narrative
Description of Event or Problem
ON (B)(6) 2021, EXTHERA RECEIVED A DATA SHEET FROM (B)(6) ALERTING OF TWO ADVERSE EVENTS OCCURRING WITH A PATIENT (DIAGNOSED WITH COVID-19 ARDS) DURING TREATMENT WITH SERAPH AND CRRT: HYPOTENSION AND DEATH DUE TO ACUTE RESPIRATORY FAILURE. AN EXTHERA EMPLOYEE REACHED OUT TO THE ATTENDING PHYSICIAN DR. (B)(6), WHO COMMUNICATED THAT THE PATIENT'S DEATH WAS NOT RELATED TO USE OF THE SERAPH DEVICE NOR TO THE PROCEDURE.
Additional Manufacturer Narrative
COMPLAINT WAS RE-EVALUATED AS PART OF COMPLAINT REMEDIATION ACTIVITIES AND DETERMINED TO BE REPORTABLE.