MAUDE Adverse Event Report: QUEST MEDICAL, INC. MPS CONSOLE; CPBP HEAT EXCHANGER

Model Number	5201260
Medical Device Problem Codes	Backflow (1064); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Quest medical is currently pending receipt of the alleged device for investigation.Once received, quest will conduct its investigation.A supplemental report will be filed at the conclusion of the investigation.
Event or Problem Description
It was reported to quest medical of an alleged issue with an mps console.The user stated that during cardioplegia delivery, back flow was noticed.It was confirmed that there were no patient complications.
Additional Manufacturer Narrative
The console was received and decontaminated.The reported issue was unable to be duplicated.Review of the log data did not reveal any reason why backflow in the delivery line was noticed.No visual defects were noted after the console was disassembled.Subsequent functional testing of the console passed all acceptance criteria.Quest has completed investigation of this complaint.Quest will continue to monitor trends for this complaint condition.
Event or Problem Description
It was reported to quest medical of an alleged issue with an mps console.The user stated that during cardioplegia delivery, back flow was noticed.It was confirmed that there were no patient complications.

• Brand Name: MPS CONSOLE
• Common Device Name: CPBP 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: 15481105
• Report Number: 1649914-2022-00022
• Device Sequence Number: 12512263
• Product Code: DTR
• UDI-Device Identifier: 20634624521265
• UDI-Public: 20634624521265
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K041979
• 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): 01/09/2023

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: 5201260
• Device Catalogue Number: 5201260
• 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: 08/26/2022
• Supplement Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 09/24/2022
• Supplement Report FDA Received Date: 01/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2016
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown