MAUDE Adverse Event Report: EXTHERA MEDICAL CORPORATION SERAPH 100; APPARATUS, HEMOPERFUSION, SORBENT

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); Hypoxia (1918); Shock (2072); Ventilator Dependent (2395); Respiratory Failure (2484)

Event Date 12/17/2021

Event Type  Death  

Event Description

Seraph 100 use for covid-19 under emergency use authorization (eua): diagnosed with covid-19 and acute hypoxic respiratory failure with a history of esrd on hd.She was admitted on (b)(6) 2021 and started with initial hd on (b)(6) 2021.After worsening respiratory failure noted, she was thought to be a candidate for seraph 100 use on (b)(6) 2021.Patient was started on hd with addition of hemofiltration device seraph 100 on (b)(6) 2021.She was also anticoagulated with a heparin drip per eua protocol but developed significant bleeding at av fistula site requiring blood transfusion and protamine sulfate use.She had a second round of seraph 100 on (b)(6) 2021 without complication.She developed worsening respiratory failure which required mechanical ventilation on (b)(6) 2021.She developed worsening shock with suspicion of mesenteric ischemia and bowel infarction.She developed cardiac arrest with cpr but expired on (b)(6) 2021.Fda safety report id#: (b)(4).

• Brand Name: SERAPH 100
• Type of Device: APPARATUS, HEMOPERFUSION, SORBENT
• Manufacturer (Section D): EXTHERA MEDICAL CORPORATION
• MDR Report Key: 13141717
• MDR Text Key: 283156829
• Report Number: MW5106397
• Device Sequence Number: 1
• Product Code: FLD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American