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

Model Number	5ND3102
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The report received states that a needle size hole was discovered in the cassette after the customer started using the device.Blood was leaking from console door.The patient had some blood loss.Cardiopledgia was administered and the disposable was replaced on bypass.No additional information has been received from the customer at this time.
Additional Manufacturer Narrative
The complaint sample has not been returned for investigation.A follow-up report will be submitted after investigation is completed.
Additional Manufacturer Narrative
An analysis of the complaint sample was not conducted because the complaint sample was not returned for investigation.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 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: daniel mckearan ; 1 allentown parkway; allen, TX 75002 ; 9723909800
• MDR Report Key: 22447972
• Report Number: 1649914-2025-00016
• Device Sequence Number: 8356972
• Product Code: DTR
• UDI-Device Identifier: 20634624530342
• UDI-Public: (01)20634624530342(11)241211(17)271211(10)74565
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 08/22/2025

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: 5ND3102
• Device Lot Number: 74565
• 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: 06/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 08/22/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown