FDA Adverse Event
Injury
Summary report: N
SERAPH 100
MDR report key: 22898959
·
Received August 26, 2025
Report
- Report Number
- 3014015528-2025-00026
- Event Type
- Injury
- Date Received
- August 26, 2025
- Date of Event
- September 21, 2021
- Report Date
- August 26, 2025
- Manufacturer
- EXTHERA MEDICAL CORPORATION
- Product Code
- QLO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
COMPLAINT WAS RE-EVALUATED AS PART OF COMPLAINT REMEDIATION ACTIVITIES AND DETERMINED TO BE REPORTABLE.
Description of Event or Problem · 0
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2666638 | SERAPH 100 | SERAPH 100 | QLO | EXTHERA MEDICAL CORPORATION | H005521 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |