MAUDE Adverse Event Report: QUEST MEDICAL, INC. MPS3 ND CONSOLE; HEAT-EXCHANGER, CARDIOPULMONARY BYPASS

Model Number	5301000ND
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was evaluated and the reported issue was duplicated.The root cause was due to a malfunctioning microswitch board.The microswitch board was replaced and the console passed all operational verification tests.Quest medical will continue to monitor complaint trends.
Event or Problem Description
The report received from the customer states that the device delivered an inappropriate volume of substrate based on the input setting.The setting was 36ml/l.1400ml of "micronido" del nido cardioplegia was intended to be administered to the patient.However, only 10.9 ml of substrate was given.Perfusionist provided no error codes and there were no patient complications.

• Brand Name: MPS3 ND CONSOLE
• Common Device Name: HEAT-EXCHANGER, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): QUEST MEDICAL, INC.; 1 allentown parkway; allen TX 75002
• Manufacturer (Section G): QUEST MEDICAL, INC.; 1 allentown parkway; allen TX 75002
• Manufacturer Contact: abel joseph ; 1 allentown parkway; allen, TX 75002 ; 9723909800
• MDR Report Key: 22851834
• Report Number: 1649914-2025-00020
• Device Sequence Number: 4419203
• Product Code: DTR
• UDI-Device Identifier: 20634624531004
• UDI-Public: (01)20634624531004(11)240227(17)340224(10)445472070
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K201984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5301000ND
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Unknown