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

Model Number	5201260
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/04/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital perfusionist reported an issue encountered with the mps2 console during use.The report stated the console had been intermittently popping the vent valve throughout multiple cases.There were no patient complications reported as a result of the alleged issue.A field service engineer will evaluate the console at the user facility.
Additional Manufacturer Narrative
Device evaluation duplicated the reported complaint condition.The fluid level sensor was replaced but the issue still existed.After the sensor replacement, the field service engineer (fse) noticed an intermittent connection with the ribbon cable from the pcsa board.The cable was replaced and the issue was no longer duplicated.The console then passed the operational verification test.Further evaluation of the fluid level sensor removed from the console and found that it has raised edges, with the contact patch always near one edge.This is the root cause of the customer complaint.

• Brand Name: MPS2 CONSOLE
• Common Device Name: CPBP HEAT EXCHANGER
• Manufacturer (Section D): QUEST MEDICAL INC; one allentown parkway; allen 75002
• MDR Report Key: 6610154
• Report Number: 1649914-2017-00044
• Device Sequence Number: 16338976
• Product Code: DTR
• UDI-Device Identifier: 20634624521265
• UDI-Public: 20634624521265
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K041979
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2017

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?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/04/2017
• Supplement Date Received by Manufacturer: 05/04/2017
• Initial Report FDA Received Date: 06/02/2017
• Supplement Report FDA Received Date: 07/23/2017
• 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