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

Model Number	5301000ND
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Electrolyte Imbalance (2196)
Date of Event	05/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device was received from (b)(6) memorial.The device error log was reviewed and it was noted that there were arrest occlusion alarms that showed to the user during the case.Based on the log data that was reviewed, it does not seem that the console caused or contributed to the complaint condition of high serum potassium.The console was found to have delievered the correct/expected amount that was intended to be delivered by the user based on the settings that were utilized during the case.Quest will continue to monitor this complaint condition.Quest has concluded its investigation of this device.
Event or Problem Description
It was reported by (b)(6) memorial of an alleged issue with mps 3 nd unit.The unit was alleged to have repeatedly errored (ec 103) while trying to deliver cardioplegia.The unit was powered down and re-started with no success.After the final dose was given and the cross clamp was removed, a blood gas level was drawn and noted a high serum potassium level.It was confirmed that there were no patient complications.

• 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: 17075669
• Report Number: 1649914-2023-00017
• Device Sequence Number: 20357218
• Product Code: DTR
• UDI-Device Identifier: 20634624531004
• UDI-Public: 20634624531004
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/05/2023

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: 5301000ND
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2023
• Initial Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2021
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown