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

Model Number	5ND3102
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The report states a leak appeared; blood was only appearing to leak.Medication was administered, there were no delays in the procedure, the leak continued throughout the cases.There were no patient complications.
Additional Manufacturer Narrative
No sample was received for analysis and thus investigation of the sample could not be completed.A photo of the leak was received showing blood leaking from the check valve to heat exchanger location.A process review was completed of the aa drug line assembly and no manufacturing or quality issues were identified.The check valve is manufactured at an external supplier the function is verified at their facility.A scar was issued to the supplier to investigate the cause of the luer leaking from the check valve and implement corrective actions.The cause of the failure cannot be traced to quest manufacturing process.This complaint resulted in a an mdr - mdr25-00024.No additional correction is required.Field action review was not completed as the cause of the report was not determined to be related to manufacturing.
Additional Manufacturer Narrative
This is a follow-up to mfr report number 1649914-2025-00024 originally submitted on 12/4/2025.Since the initial submission, two additional complaints have been received (from the same reporting source) involving the same device/model/part number product code.5nd3102 lot: 77167, exhibiting the same reported leak confirmed from the check valve to heat exchanger port.Event statement on 11/20/2025 for (b)(4) (related to initial (b)(4)): the report states there was a leak in a disposable identical to the complaint reported in (b)(4) and (b)(4).In these complaints, the check valve luer connection of the drug line to the hex was leaking blood.No sample was received (as indicated in supplimental information) for analysis and thus investigation of the sample could not be completed.A photo of the leak was received showing blood leaking from the check valve to heat exchanger location.A process review was completed of the aa drug ling assembly and no manufacturing or quality issues were identified.The check valve is manufactured at an external supplier the function is verified at their facility.The cause of the failure cannot be traced to quest manufacturing process.A scar was issued to the supplier to investigate the cause of the luer leaking from the check valve and implement corrective actions.This follow-up provides this updated complaint count and reaffirms the initial analysis.The total number of reported devices for this event is now three.
Additional Manufacturer Narrative
This is a follow-up to mfr report number 1649914-2025-00024 originally submitted on 12/4/2025.Since the initial submission, two additional complaints have been received (from the same reporting source) involving the same device/model/part number product code.5nd3102 lot: 77167, exhibiting the same reported leak confirmed from the check valve to heat exchanger port.Event statement for (b)(4) (related to initial (b)(4)): the report states a leak appeared; blood was only appearing to leak.This happened first earlier this week, before (b)(6) 2025.Medication was administered, there were no delays in the procedure, the leak continued throughout the cases.There were no patient complications.No sample was received (as indicated in supplimental information) for analysis and thus investigation of the sample could not be completed.A photo of the leak was received showing blood leaking from the check valve to heat exchanger location.A process review was completed of the aa drug ling assembly and no manufacturing or quality issues were identified.The check valve is manufactured at an external supplier the function is verified at their facility.The cause of the failure cannot be traced to quest manufacturing process.A scar was issued to the supplier to investigate the cause of the luer leaking from the check valve and implement corrective actions.This follow-up provides this updated complaint count and reaffirms the initial analysis.The total number of reported devices for this event is now three.

• Brand Name: MPS3 ND DELIVERY SET
• 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: donlene nyazai ; 1 allentown parkway; allen, TX 75002
• MDR Report Key: 23716742
• Report Number: 1649914-2025-00024
• Device Sequence Number: 18367894
• Product Code: DTR
• UDI-Device Identifier: 20634624530342
• UDI-Public: (01)20634624530342(11)250918(17)280918(10)77167
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/13/2026

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 Expiration Date: 09/18/2025
• Device Model Number: 5ND3102
• Device Lot Number: 77167
• 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: 11/07/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 01/13/2026; 01/13/2026; 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown