MAUDE Adverse Event Report: QUEST MEDICAL, INC MPS 3 CONSOLE; CPBP HEAT EXHANGER

Model Number 5301000

Device Problems Excess Flow or Over-Infusion (1311); Inaccurate Delivery (2339)

Patient Problems Overdose (1988); Electrolyte Imbalance (2196)

Event Date 08/05/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation is underway.A follow up report will be submitted after the investigation is completed.This is report 1 of 2 since the incident allegedly occured with two patients.The second report will be filed under report# 1649914-2020-00034.

Event Description

The report received states that over delivery of the potassium and additives were experienced during the first 2 cases with mps 3.This resulted in a hyperkalemic state for the patient that was able to be corrected on bypass by the perfusionist & anesthesiologists by giving insulin.

Manufacturer Narrative

The complaint sample was evaluated.Results from the investigation identified a software defect as the root cause of the reported complaint condition.The software was updated to ensure the device piston is left in its current position when flow is stopped instead of pulling the piston back to the relief position.Verification testing conducted on the updated software demonstrated the effectiveness of the change.The manufacturing process for the device was also updated to include multi-dose test cases.

• Brand Name: MPS 3 CONSOLE
• Type of Device: CPBP HEAT EXHANGER
• Manufacturer (Section D): QUEST MEDICAL, INC; one allentown parkway; allen, tx
• MDR Report Key: 10491902
• MDR Text Key: 207932169
• Report Number: 1649914-2020-00033
• Device Sequence Number: 1
• Product Code: DTR
• Combination Product (y/n): N
• PMA/PMN Number: K200438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/03/2020

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: 5301000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/11/2020
• Initial Date FDA Received: 09/03/2020
• Supplement Dates Manufacturer Received: 08/11/2020
• Supplement Dates FDA Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention