MAUDE Adverse Event Report: QUEST MEDICAL, INC. MPS 2 CONSOLE; CPBP HEAT EXHANGER

Model Number 5201260

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2020

Event Type  malfunction  

Manufacturer Narrative

The console will be evaluated when it is received, and a follow up medwatch will be submitted if additional information becomes available.

Event Description

A report was received, stating that during the first dose of cardioplegia, the mps console stopped during the induction.The user was able to restore antegrade flow, but the quantities calculated by the console jumped from 600ml to 1200ml with little dosing being performed.After the initial dose, the user did some troubleshooting, but the same error message was displayed, which is when she notified the surgeon she was going to change out the console.As a result, one dose of cardioplegia was not given to the patient (after the distal anastomoses of the vein).This console will be returned to quest medical for investigation/repair.

Manufacturer Narrative

The device was evaluated and the reported complaint condition could not be duplicated.The console was disassembled to check for damage, defects, or fluid intrusion and none was found.The console was reassembled and tested, and successfully passed all operational verification testing.

• Brand Name: MPS 2 CONSOLE
• Type of Device: CPBP HEAT EXHANGER
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• MDR Report Key: 10931608
• MDR Text Key: 219344931
• Report Number: 1649914-2020-00038
• Device Sequence Number: 1
• Product Code: DTR
• Combination Product (y/n): N
• PMA/PMN Number: K173716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/17/2021

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: No Information
• Device Model Number: 5201260
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/02/2020
• Initial Date FDA Received: 12/02/2020
• Supplement Dates Manufacturer Received: 11/02/2020
• Supplement Dates FDA Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1