MAUDE Adverse Event Report: QUEST MEDICAL, INC. MPS 3ND; MPS 3ND CONSOLE

Model Number	5301000ND
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Electrolyte Imbalance (2196)
Date of Event	01/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that a student initiated the setup prior to priming.The student installed the cartridge without the plunger, contrary to the instructions outlined in the ifu.This caused leakage of fluids over the console.The perfusionist identified the issue and replaced the cartridge, completed the priming process, and initiated the case.The alleged issue then occured during the procedure.Quest is waiting for the console.Investigation will initiate upon the receipt of console.
Event or Problem Description
A perfusionist at (b)(6), reported an issue with an mps3 nd console to a quest representative.It was stated that during a case, the arrest agent appeared to deliver its contents faster than expected.When a refill was attempted, the plunger unexpectedly pushed the entire contents out at once.A subsequent refill test using saline yielded the same result.It was disclosed that during the initial setup, the cartridge was installed without the plunger attached, causing approximately 10-20cc of fluid to spill onto the unit.This incident resulted in an extended on-pump time and required the patient to undergo a blood transfusion, as excess potassium needed to be purged from the mps disposable.The console has been removed from service and will be returned to quest medical for investigation.
Additional Manufacturer Narrative
The console was received, decontaminated, and thoroughly inspected.During the inspection, dried fluid was observed on the arrest pump microswitch and actuator, while no damage was found on the drug piston rubber cover drum.This suggests that fluid intrusion occurred due to the incorrect installation of an arrest cartridge without a plunger, allowing pressurized fluid to accumulate around the drug piston.The affected components were replaced, and the device successfully passed all operational verification testing.The root cause was determined to be operator error, specifically the installation of an arrest cartridge without a plunger, which led to the reported issue.At this time, no corrective action is being implemented, as the failure remains an isolated occurrence.However, quest medical will continue to monitor this issue for any emerging trends and take appropriate action if necessary.
Event or Problem Description
A perfusionist at (b)(6) in (b)(6), ont, reported an issue with an mps3 nd console to a quest representative.It was stated that during a case, the arrest agent appeared to deliver its contents faster than expected.When a refill was attempted; the plunger unexpectedly pushed the entire contents out at once.A subsequent refill test using saline yielded the same result.It was disclosed that during the initial setup, the cartridge was installed without the plunger attached, causing approximately 10-20cc of fluid to spill onto the unit.This incident resulted in an extended on-pump time and required the patient to undergo a blood transfusion, as excess potassium needed to be purged from the mps disposable.The console has been removed from service and will be returned to quest medical for investigation.

• Brand Name: MPS 3ND
• Common Device Name: MPS 3ND CONSOLE
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002 4211
• Manufacturer (Section G): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002 4211
• Manufacturer Contact: swathi kiran sarihaddu ; one allentown parkway; allen, TX 75002-4211 ; 9723326338
• MDR Report Key: 21245924
• Report Number: 1649914-2025-00001
• Device Sequence Number: 12887967
• Product Code: DTR
• UDI-Device Identifier: 20634624531004
• UDI-Public: 20634624531004
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K201984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 5301000ND
• Device Catalogue Number: 5301000ND
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2024
• 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