MAUDE Adverse Event Report: EXTHERA MEDICAL CORPORATION SERAPH 100 MICROBIND AFFINITY BLOOD FILTER; BLOOD PURIFICATION DEVICE

Model Number SERAPH 100

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Thrombocytopenia (4431)

Event Date 03/10/2021

Event Type  Injury  

Manufacturer Narrative

Reporting delayed due to need to create an account for reporting through webtrader/esg.Manufacturer fei code was not in test system, so additional actions were required behind the scene by fda representatives in order for test submission to cdrh to be successful.

Event Description

Patient (b)(6) is a (b)(6)-year-old female, with no significant medical history, who first tested positive for sars-cov-2 on (b)(6) 2021 via a nasal swab pcr.She was admitted to the hospital, directly to the icu, on (b)(6) 2021 for pneumonia.As part of her covid-19 treatment, she received redemsivir, azithromycin, and ceftriaxone.She continued to require icu level care, and her clinicians decided to use the seraph-100® for her early ards as well as severe and life-threatening disease, as defined in the eua.Her clinicians ordered for a 48-hour treatment course, consisting of two filters to run for 24 hours each.No concurrent extracorporeal therapies were provided.Heparin was started prior to the first filter, with 25,000 units at 03:33 on (b)(6) and a drip of 12 units/kg/hr.The first seraph-100® filter started (b)(6) 2021 at 13:00 and was discontinued (b)(6) 2021 at 13:00.A second filter was started immediately after, at 13:00 on (b)(6) 2021.Her platelet count was noted to be decreasing on (b)(6) and it continued into (b)(6).Initially, there was concern for heparin-induced thrombocytopenia (hit), so her heparin drip was discontinued.Hit is contraindication of seraph-100® therapy, per the eua ifu.As a result, the second filter was discontinued early, on (b)(6) 2021 at 04:44.The site reported this event as thrombocytopenia - expected yet serious, and possibly related to both the seraph-100® filter and treatment.No bleeding or other symptoms were observed.The patient's hit antibody and optical density (od) labs returned negative.Her thrombocytopenia resolved without sequelae on (b)(6) 2021.

• Brand Name: SERAPH 100 MICROBIND AFFINITY BLOOD FILTER
• Type of Device: BLOOD PURIFICATION DEVICE
• Manufacturer (Section D): EXTHERA MEDICAL CORPORATION; 757 arnold drive; suite b; martinez CA 94553
• Manufacturer (Section G): EXTHERA MEDICAL CORPORATION; 757 arnold drive; suite b; martinez CA 94553
• Manufacturer Contact: erdie de peralta ; 757 arnold drive; suite b; martinez, CA 94553 ; 9258392079
• MDR Report Key: 11840605
• MDR Text Key: 251124253
• Report Number: 3014015528-2021-00001
• 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: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/18/2021

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
• Device Expiration Date: 09/01/2023
• Device Model Number: SERAPH 100
• Device Lot Number: J018120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2021
• Initial Date FDA Received: 05/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: COVIDIEN - FEEDING PUMP; HEPARIN DRIP; SERVO MAQUET - VENTILATOR; SYSTEM ONE NXSTAGE; TEMPORARY HD CATHETER - UNKNOWN MANUFATURER
• Patient Outcome(s): Life Threatening
• Patient Age: 67 YR
• Patient Weight: 51