MAUDE Adverse Event Report: QUANTA DIALYSIS TECHNOLOGIES LTD SC+ HAEMODIALYSIS DEVICE

Model Number SC-12410

Device Problem Use of Device Problem (1670)

Patient Problems Air Embolism (1697); Cardiac Arrest (1762); Dizziness (2194)

Event Date 01/25/2023

Event Type  Injury  

Manufacturer Narrative

This report is being submitted again to fda due to receiving email report from fda indicating original report had invalid mfr number.The original report number was 0000000-2023-09001.The information provided in this report is similar to report 0000000-2023-09001.(b)(4).As part of the sc+ safety system the device incorporates an air in blood sensor which, if activated by the presence of air in the extracorporeal circuit, triggers the machine to stop the blood pump to prevent air being pushed into the patient.The patient/user is alerted by a warning message on the screen and audible alarm that air has been detected.A review of the treatment data from the machine shows that air in blood safety system passed self check at the start of treatment and no air was detected in the lines during the treatment.If, at anytime, the patient disconnects their catheter from the blood tube set they are required to clamp the catheter closed to ensure air is not drawn into the catheter and subsequently the body.Quanta is trying to ascertain from speaking to the hospital if the patient disconnected the cannula at any time during treatment and whether use error meant they did not close the clamp of their catheter when they did this.Presently, there is no evidence to suggest malfunction in the sc+ led to this event but we continue to work with the clinic to understand the root cause of the incident and whether the sc+ may have contributed in any way to the event occurring.Quanta will provide fda with a follow-up report of our investigation.Moreover, due to the incident occurring in the united kingdom quanta has reported incident to mhra ((b)(4)).

Event Description

Quanta dialysis technology received an adverse event report on (b)(6), 2023.The incident occurred on (b)(6), 2023 at (b)(6) hospital in london, united kingdom.The clinic reported that, following dialysis treatment a female patient became unresponsive.Following ct scans the hospital confirmed that the patient had suffered from an air embolism.It was reported that the patient connected their venous line to the saline line and commenced washback/rinseback.After completing full washback/rinseback (i.E.After returning all the blood from the extracorporeal circuit into the body), the patient had reported to a clinician that she felt dizzy and unwell.The patient became unresponsive and a nurse administered gelofusine to the patient and cpr was performed.The patient was taken into intensive care.

• Brand Name: SC+ HAEMODIALYSIS DEVICE
• Type of Device: SC+
• Manufacturer (Section D): QUANTA DIALYSIS TECHNOLOGIES LTD; the woods; haywood road; warwick, warwickshire CV34 5AH; UK CV34 5AH
• Manufacturer (Section G): QUANTA DIALYSIS TECHNOLOGIES LTD; the woods; haywood road; warwick, warwickshire CV34 5AH; UK CV34 5AH
• Manufacturer Contact: chris rule ; the woods; haywood road; warwick, warwickshire CV34 -5AH ; UK CV34 5AH
• MDR Report Key: 17982515
• MDR Text Key: 326233805
• Report Number: 3013536188-2023-00008
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K210661
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/23/2023

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: Lay User/Patient
• Device Model Number: SC-12410
• Device Catalogue Number: SC-12410
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2023
• Initial Date FDA Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization