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

Model Number 5301000ND

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Electrolyte Imbalance (2196)

Event Date 05/08/2023

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 316782008
• Report Number: 1649914-2023-00017
• Device Sequence Number: 1
• Product Code: DTR
• UDI-Device Identifier: 20634624531004
• UDI-Public: 20634624531004
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201984
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 05/08/2023
• Initial Date FDA Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention