MAUDE Adverse Event Report: QUEST MEDICAL, INC. MPS 3 ND MYOCARDIAL PROTECTION SYSTEM; CPBP HEAT EXCHANGER

Model Number	5301000ND
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medwatch report # mw5110455 was received by quest medical.The report stated that when attempting to run cardiplegia to the field, the cardioplegia pump generated an alarm.It was cleared and allegedly the unit was still not functional.The report stated that there were no patient complications.
Additional Manufacturer Narrative
Quest medical reached out to (b)(6) to obtain additional information regarding this medwatch report and has not received any response.Quest medical will file a supplemental report should any additional information become available and will continue to monitor complaint trends for the reported condition.

• Brand Name: MPS 3 ND MYOCARDIAL PROTECTION SYSTEM
• 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: 15135910
• Report Number: 1649914-2022-00018
• Device Sequence Number: 5307991
• Product Code: DTR
• UDI-Device Identifier: 20634624531004
• UDI-Public: 20634624531004
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/29/2022

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 Model Number: 5301000ND
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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