MAUDE Adverse Event Report: QUEST MEDICAL, INC. MPS2 CONSOLE; CPBP HEAT EXCHANGER

Model Number 5201260

Device Problems Detachment Of Device Component (1104); Fluid/Blood Leak (1250); Hole In Material (1293); Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/24/2017

Event Type  malfunction  

Event Description

The biomedical engineer reported an issue encountered with the mps2 console during use.The report stated the console continuously popped the vent valve, and the user would have to manually clamp the vent line.There were no patient complications reported as a result of the alleged issue.The console was returned to the manufacturer for evaluation.

Manufacturer Narrative

The console was received and evaluated.The reported complaint was confirmed in the log data.Fluid intrusion was found on the solenoid driver board which was the cause for the vent valve errors.It appeared that the fluid came in from a hole/ tear in the shroud tube that's on the water line underneath the hex block.The shroud was replaced with a new shroud and the solenoid driver board was replaced and the console was reassembled.The root cause of the hole/tear in the shroud tube is unknown.Complaints will be monitored for trending.

• Brand Name: MPS2 CONSOLE
• Type of Device: CPBP HEAT EXCHANGER
• 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: amy clendening-wheeler ; one allentown parkway; allen, TX 75002
• MDR Report Key: 6809376
• MDR Text Key: 83651192
• Report Number: 1649914-2017-00064
• Device Sequence Number: 1
• Product Code: DTR
• UDI-Device Identifier: 20634624521265
• UDI-Public: 20634624521265
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041979
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 5201260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention