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

Model Number	5301000ND
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for investigation.A follow-up report will be submitted after investigation is completed.
Event or Problem Description
The report states that additive was working fine but on the last couple doses, it was not working anymore and no additive was being added.The additive had to be manually delivered to the patient.There were no patient complications resulting from the issues.
Additional Manufacturer Narrative
An analysis of the device was not conducted because the device was not returned for investigation.The console logs were reviewed and there were no alarms related to drug delivery.The reported problem was not confirmed.The device history record and manufacturing process was reviewed, and inspection report shows that no specific manufacturing yield issue were reported similar to the reported complaint condition.Quest medical will continue to monitor complaints for trends.

• Brand Name: MPS3 ND CONSOLE
• Common Device Name: CARDIOPULMONARY BYPASS HEAT EXCHANGER
• 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: daniel mckearan ; 1 allentown parkway; allen, TX 75002 ; 9723909800
• MDR Report Key: 21339502
• Report Number: 1649914-2025-00003
• Device Sequence Number: 8432004
• Product Code: DTR
• UDI-Device Identifier: 20634624531004
• UDI-Public: (01)20634624531004(11)210125(17)310123(10)4050061108
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 08/29/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown