SERAPH 100

Description of Event or Problem

PATIENT (FEMALE, 52 YEARS OLD, 75KG, NON-HISPANIC AFRICAN AMERICAN, DIAGNOSED WITH COVID-19 AND ACUTE HYPOXIC RESPIRATORY FAILURE WITH A HISTORY OF END-STAGE RENAL DISEASE [ESRD] ON HEMODIALYSIS [HD]) EXPERIENCED WORSENING RESPIRATORY FAILURE, SHOCK AND DEATH BY CARDIAC ARREST. FIRST COMMUNICATION FROM THE PHYSICIAN ((B)(6), MD FROM (B)(6)) OCCURRED (B)(6) 2021 IN WHICH HE ASKED IF THE SERAPH COULD BE USED OUTSIDE THE ICU AND STATED THAT "OUR RENAL GUY STARTED USING THIS IN THE FLOOR PATIENTS AND NOW WE ARE GETTING INTO SOME ISSUES." THE POTENTIAL COMPLAINT WAS NOT NOTED AND NO FOLLOW-UP WITH THE PHYSICIAN WAS ATTEMPTED AT THAT TIME. ON (B)(6) 2022, FDA NOTIFIED EXTHERA THAT MDR #MW5106397 HAD BEEN FILED BY THE PHYSICIAN, WHICH CONTAINED THE FOLLOWING DESCRIPTION OF THE EVENT: "SERAPH 100 USE FOR COVID-19 UNDER [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." MDR STATES THE DATE OF EVENT IS 17 DEC 2021 BUT UNCLEAR WHICH EVENT THIS REFERS TO IN THE SUBMITTED REPORT (WHICH HAS DATES REDACTED). REPORT WAS SUBMITTED 29 DEC 2021. BECAUSE THE MDR AS SUBMITTED STATES A MEDICAL DEVICE PROBLEM CODE OF 4001 [IMDRF: A01] INDICATING "PATIENT DEVICE INTERACTION PROBLEM," THERE IS AN ALLEGATION THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE PATIENT'S ADVERSE EVENTS.

Additional Manufacturer Narrative

COMPLAINT WAS RE-EVALUATED AS PART OF COMPLAINT REMEDIATION ACTIVITIES AND DETERMINED TO BE REPORTABLE.