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

Model Number	5201260
Medical Device Problem Codes	Fluid/Blood Leak (1250); Hole In Material (1293); Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/24/2017
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: CPBP HEAT EXCHANGER
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• MDR Report Key: 6809376
• Report Number: 1649914-2017-00064
• Device Sequence Number: 10795483
• Product Code: DTR
• UDI-Device Identifier: 20634624521265
• UDI-Public: 20634624521265
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K041979
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2017

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
• Operator of Device: Other
• Device Model Number: 5201260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/24/2017
• Supplement Date Received by Manufacturer: 07/24/2017
• Initial Report FDA Received Date: 08/21/2017
• Supplement Report FDA Received Date: 10/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention