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

Model Number SC-12410

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Hypovolemia (2243)

Event Date 07/01/2022

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 0000000-2022-09000.The information provided in this report is similar to report 0000000-2022-09000.(b)(4).Following receipt of the incident report from the hospital, quanta performed a detailed review of the machine log associated with the treatment.The review has shown that the sc+ was operating as intended and no faults with the device were identified.Therefore, the results of our investigation have concluded that the adverse event was caused by user error and the sc+ shows no sign of fault.The conclusion that the event resulted from user error is supported by the feedback provided by the hospital nurse which stated that the patient had reversed her venous and arterial access on the central venous catheter.Lot release records and dhr records were reviewed and the product lot met all acceptance criteria.In addition, as this incident took place in united kingdom, quanta reported the incident to mhra.Trending will be monitored for this and or similar complaints.

Event Description

(b)(6) hospital reported a user error had occurred at the end of a dialysis treatment: at the end of a haemodialysis treatment session, a patient is required to return the blood that remains in the extracorporeal circuit back into the body.This is normally achieved by connecting the arterial line to a saline bag and flushing the line with saline solution.However, in the reported incident, the self-care patient incorrectly connected their venous line to the saline bag instead of the arterial line.The patient attempted to return the blood by starting the blood pump which resulted in blood being pushed into the saline bag instead of saline solution being pushed into the blood circuit.A hemodialysis nurse spotted the use error and rectified the situation by correctly connecting the lines and returning the blood back to the patient.The hospital reported that the patient initially experienced hypovolemic symptoms (blurry vision and dizziness) which then stopped after the blood was successfully returned to the patient.No medication was administered and no blood loss was reported.

• 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: 18008646
• MDR Text Key: 326554252
• Report Number: 3013536188-2023-00009
• 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: 10/26/2023

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: 07/01/2022
• Initial Date FDA Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2022
• 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): Other