SERAPH 100
Received May 15, 2025 · Event occurred Apr 8, 2024
Report 3014015528-2025-00007 · MDR key 22023624
Device
Product problems
- Patient Device Interaction Problem
- Patient Device Interaction Problem
Patient
NA · Male
- Low Blood Pressure/ Hypotension
- Low Blood Pressure/ Hypotension
Narrative
Additional Manufacturer Narrative
THIS WAS STATED IN THE NYT, SEE (B)(6). "A START-UP CLAIMED ITS DEVICE COULD CURE CANCER. THEN PATIENTS BEGAN DYING." THE NEW YORK TIMES, (B)(6) 2025. THE MANUFACTURER FOLLOWED UP WITH THE FACILITY IN (B)(6) WHERE THE CLAIMED ADVERSE EVENTS TOOK PLACE AND WITH THE TREATING PHYSICIAN. THE FACILITY HAS STATED THAT IT WAS NOT AWARE OF ANY ADVERSE EVENTS. THE PHYSICIAN HAS NOT RESPONDED.
Description of Event or Problem
THIS INFORMATION WAS REPORTED PUBLICLY BY THE NEW YORK TIMES. SEE (B)(6). "A START-UP CLAIMED ITS DEVICE COULD CURE CANCER. THEN PATIENTS BEGAN DYING." THE NEW YORK TIMES, (B)(6) 2025. AS REPORTED IN NYT ARTICLE, PATIENT P2 (IDENTIFIED AS MALE, AGE UNKNOWN, DIAGNOSED WITH COLON CANCER) EXPERIENCED A DECREASE IN BLOOD PRESSURE (HYPOTENSION) DURING HIS THIRD FILTERING SESSION. DATE UNKNOWN BUT ASSUMED TO BE BETWEEN FIRST FILTERING SESSION AND DATE HE LEFT (B)(6). THE ARTICLE STATES THAT THESE TREATMENTS TOOK PLACE OUTSIDE THE UNITED STATES, IN ANTIGUA. THE DEVICE WAS BEING USED OFF-LABEL FOR THE TREATMENT OF CANCER, OUTSIDE OF THE UNITED STATES IN (B)(6).