MAUDE Adverse Event Report: QUEST MEDICAL, INC. QUEST MPS3 CARDIOPLEGIA DELIVERY SYSTEM; HEAT-EXCHANGER, CARDIOPULMONARY BYPASS

Device Problem Pumping Stopped (1503)

Patient Problem Cardiac Arrest (1762)

Event Date 06/26/2022

Event Type  Injury  

Event Description

Our cv surgery program has had frequent issues with the quest mps3 cardioplegia delivery system.Most of the issues have been "nuisances" and have not directly affected patient care.However, in this particular instance, i felt the product was very unsafe.We initiated cardiopulmonary bypass and then crossclamped the heart.We gave an initial antegrade dose of cardioplegia of 1,500ml that had no issues.Halfway through the retrograde dose, an alarm popped up on the quest: "arrest pump piston sensor error verify arrest cartridge installation arrest pump is off" and the potassium delivery pump shut off.I made sure the cartridge was properly seated and pressed retest, at which point the potassium delivery pump turned back on.This happened multiple times throughout the procedure.We did have a poor cardiac arrest, which was probably contributable to the intermittent addition of potassium in our cardioplegia dosing.I asked the clinical reps later what could be done to deliver potassium if this were to happen again and their reply was to break the stopcock that is used to prime the "arrest pump" with potassium and manually deliver potassium with a syringe.Fda safety report id# (b)(4).

• Brand Name: QUEST MPS3 CARDIOPLEGIA DELIVERY SYSTEM
• Type of Device: HEAT-EXCHANGER, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): QUEST MEDICAL, INC.
• MDR Report Key: 15067305
• MDR Text Key: 296368341
• Report Number: MW5110988
• Device Sequence Number: 1
• Product Code: DTR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White