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

Model Number 5201260

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was evaluated and he reported ec004 was not duplicated and the log data could not be retrieved.In the console ten codes of ec284 was found.A wet lab was performed and the ec284 was duplicated.The fluid level sensor was removed and replaced.After the replacement, f6 software was reinstalled to clear and remove the corrupted files.Mps console was then tested and passed the operational verification test.The root cause of the reported ec004 is unknown.

Event Description

A report was received regarding an alleged issue encountered during use of the console.The report states that during a case, the console displayed ec004.The user power cycled a few times where the message was observed after each power cycle.The console was turned off and on again and this resolved the issue.There were no reported patient complications resulting from the issue.

• Brand Name: MPS 2 CONSOLE
• Type of Device: CPBP HEAT EXHANGER
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• Manufacturer (Section G): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• Manufacturer Contact: tosan onosode ; one allentown parkway; allen, TX 75002 ; 9723326338
• MDR Report Key: 8446288
• MDR Text Key: 139822986
• Report Number: 1649914-2019-00016
• Device Sequence Number: 0
• Product Code: DTR
• Reporter Country Code: US
• PMA/PMN Number: K173716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5201260
• Device Lot Number: 3017
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1