MAUDE Adverse Event Report: SEASTAR MEDICAL, INC. SELECTIVE CYTOPHERETIC DEVICE (SCD); ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Cardiogenic Shock (2262); Respiratory Failure (2484); Renal Impairment (4499)

Event Date 12/06/2022

Event Type  Death  

Event Description

A 34-year-old female with initials (b)(6) arrived at the (b)(6) hospital emergency room on (b)(6) suffering from abdominal pain with further assessments identifying a deceased fetus at 29 weeks in utero.Over the next couple hours, the patient's condition declined dramatically resulting in cardiogenic shock, respiratory failure, and acute kidney injury.Conventional intervention included fluid resuscitation, intubation, and cannulation on veno-arterial extracorporeal life support (ecls).Due to the acute nature of the subject's condition and the need for continuous renal replacement therapy (crrt), emergency use request was pursued for scd therapy through the manufacturer, seastar, and a case review was conducted via phone call per (b)(6) policy with mr.(b)(6) regional director, human research protection chair, both authorizing emergency use pathway for scd therapy.The device, selective cytopheretic device (scd), was spliced inline into a nxstage crrt machine post fl60nr filter with a car-124-c cartridge and initiated at 0105, (b)(6) 2022.Citrate was infused proximal to the patient within the crrt arterial drain line to decrease the ionized calcium <0.4 within the nxstage circuit and calcium chloride was returned to the quinton catheter to replenish the patient's calcium levels.The patient's ionized calcium levels were collected initially after 2 hours until the subject's ionized calcium levels were within the range of 1.05-1.25, then extended to every 6 hours.The mhs administrative director of the cardiovascular intensive care unit (cvicu),(b)(6), provided administrative support to safely administer the device by assisting with logistical demands and nursing assignments for primers and bedside nurses, trained in the care of patients on ecls and crrt.Due to the severity of the patient's condition, the family chose to withdraw care on (b)(6) 2022, by discontinuing ecls.No device related adverse events were identified.For further descriptions and details, please contact my office at (b)(6).

• Brand Name: SELECTIVE CYTOPHERETIC DEVICE (SCD)
• Type of Device: ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
• Manufacturer (Section D): SEASTAR MEDICAL, INC.
• MDR Report Key: 16015627
• MDR Text Key: 305824047
• Report Number: MW5113858
• Device Sequence Number: 1
• Product Code: KOC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 34 YR
• Patient Sex: Female