MAUDE Adverse Event Report: QUEST MEDICAL INC MPS2 DELIVERY SET; CARDIOPULMONARY BYPASS HEAT EXCHANGER

Model Number	5001102
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The report states that the customer had an issue with product 5001102 during an aortic valve replacement.It was reported that contact between blood and circulating water while using mps2 on a patient.Blood purification was performed during extracorporeal circulation, and no adverse event occurred with the patient.The mps delivery set in question was discontinued and another circuit was used.
Additional Manufacturer Narrative
Quest medical is continuing it's investigation.
Additional Manufacturer Narrative
The suspect device was received by quest medical on 03/29/2023.Various tests were run to verify the presence of leaking in the disposable set at various pressure levels.The complaint condition could not be replicated.The disposable could not be confirmed as leaking and seems to have been functioning as intended.Quest medical has concluded its investigation of this device.Quest will continue to monitor complaint trends for this complaint condition.

• Brand Name: MPS2 DELIVERY SET
• Common Device Name: CARDIOPULMONARY BYPASS HEAT EXCHANGER
• Manufacturer (Section D): QUEST MEDICAL INC; one allentown pkwy; allen TX 75002
• Manufacturer (Section G): QUEST MEDICAL; one allentown pkwy; allen TX 75002
• Manufacturer Contact: gail sauers ; one allentown pkwy; allen, TX 75002 ; 9842639140
• MDR Report Key: 16726399
• Report Number: 1649914-2023-00014
• Device Sequence Number: 7226314
• Product Code: DTR
• UDI-Device Identifier: 00634624501126
• UDI-Public: 00634624501126
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K953838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2023

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: 5001102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2023
• Supplement Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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