MAUDE Adverse Event Report: QUEST MEDICAL, INC. MPS DELIVERY SET; CBPB HEAT EXCHANGER

Model Number	5001102-AS
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A report was received from a customer regarding an alleged issue which occured during use of the device.The report states that, during the surgery, an alleged leak was found from the chamber arrest chamber, where the tube leaves the bag.As a result, additional cardioplegia solution was required to be administered.It was confirmed with the customer that there were no patient complications.
Additional Manufacturer Narrative
The device was evaluated and leaking was confirmed.A suspected root cause for this is inadequate solvent bonding at the area where the leak was seen.As part of a continuous improvement initiative, quest qualified and implemented an automatic solvent dispenser to enhance consistency of the solvent bonding.This set was confirmed to have been manufactured prior to implementation of the solvent dispenser.Quest will continue to monitor complaint trends.

• Brand Name: MPS DELIVERY SET
• Common Device Name: CBPB 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: brian hedden ; 1 allentown parkway; allen, TX 75002 ; 9723326311
• MDR Report Key: 13423384
• Report Number: 1649914-2022-00001
• Device Sequence Number: 4034172
• Product Code: DTR
• UDI-Device Identifier: 00634624521124
• UDI-Public: 00634624521124
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K953838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/02/2022

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: 03/09/2024
• Device Model Number: 5001102-AS
• Device Lot Number: 0620031M08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2021
• 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