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

Model Number 5001102

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2023

Event Type  malfunction  

Event 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.

Manufacturer Narrative

Quest medical is continuing it's investigation.

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
• Type of Device: 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
• MDR Text Key: 313154628
• Report Number: 1649914-2023-00014
• Device Sequence Number: 1
• Product Code: DTR
• UDI-Device Identifier: 00634624501126
• UDI-Public: 00634624501126
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 5001102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 03/15/2023
• Initial Date FDA Received: 04/12/2023
• Supplement Dates Manufacturer Received: 03/15/2023
• Supplement Dates FDA Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1