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

Model Number MPS 2

Device Problems Improper Flow or Infusion (2954); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 03/15/2021

Event Type  Injury  

Event Description

The mps module #3710 on the bypass machine which had just returned from being serviced malfunctioned while on bypass.I was delivering my last dose of cardioplegia when this happened.My potassium packet had 25ml of potassium in it.I had my machine set at 2 meq/1.When i turned on the machine to deliver there was a delay before the automatic clamp opened.Once the automatic clamp opened, at 17:34, it immediately bolused the entire 25mls in to the cardioplegia circuit.That dose went into the patient and caused an extra 45 minutes on bypass while we had to wait for the potassium to wash out and the heart to return to a normal rhythm.

• Brand Name: QUEST MEDICAL, INC.
• Type of Device: MPS 2 CONSOLE
• Manufacturer (Section D): QUEST MEDICAL, INC. ; one allentown pkwy; allen TX 75002
• MDR Report Key: 11626934
• MDR Text Key: 244444867
• Report Number: 11626934
• Device Sequence Number: 1
• Product Code: DTR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MPS 2
• Device Catalogue Number: 5201260
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/01/2021
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/16/2021
• Device Age: 15 MO
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 67