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 Low Blood Pressure/ Hypotension (1914)

Event Date 04/20/2022

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 0000000-2022-09003.The information provided in this report is similar to report 0000000-2022-09003.Udi: (b)(4) the hospital gave patient 15 litres of oxygen via a re-breath mask and became unresponsive for approximately 10 seconds, a pulse was still felt during this time.The patient's blood pressure dropped to 74/48, 500ml of gelofusine was administered through venous line and the patient became responsive again.The patient reported feeling lightheaded again for 15 minutes and clinical staff attached a 500ml saline bag to the patient.The patient was able to sit up and her blood pressure was recorded as 101/62.A subsequent transfusion of 2 units of blood was given to the patient.The hospital estimated that the patient had lost approximately 1 litre of blood.However, a review of the machine service logs suggests that approximately 650ml of blood was lost (350ml that was pushed into the saline bag, and 300ml by disposing the extracorporeal circuit without completing washback).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 hospital report which states that the patient had switched their venous and arterial access on their catheter earlier in the treatment which subsequently led to confusion.Swapping arterial and venous access around is a fairly common clinical practice when patients are experiencing access issues that are resulting in high venous or arterial pressure.From the feedback provided by the hospital it appears that the patient has become confused and had assumed, that because she had switched the access on her catheter, that she needed to apply this reversal to the bloodlines as well.This was an incorrect assumption and ultimately led to the occurrence of the event.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) hospitals reported on (b)(6) 2022 to quanta dialysis technologies that a user error had occurred at the end of a dialysis treatment.At the end of a hemodialysis treatment session, the self-care patient incorrectly connected their venous line to the saline bag.The patient then attempted to commence washback of blood resulting in approximately 350ml of the patient's blood being pushed into the saline bag.As a result of this, the patient started to feel unwell and requested assistance from clinical staff who identified the error.

• 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: 18008714
• MDR Text Key: 326555509
• Report Number: 3013536188-2023-00010
• 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: Other
• 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: 04/21/2022
• Initial Date FDA Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention