• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

QUANTA DIALYSIS TECHNOLOGIES LTD SC+ HAEMODIALYSIS DEVICE Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key18008646
MDR Text Key326554252
Report Number3013536188-2023-00009
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K210661
Number of Events Reported1
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 NumberSC-12410
Device Catalogue NumberSC-12410
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/01/2022
Initial Date FDA Received10/26/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/05/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
-
-