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	03/28/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital perfusionist reported an issue encountered with the mps2 console during use.He reported that the console displayed an error code for "right motor stuck" when he was attempting to give a hotshot at the end of a procedure.The perfusionist stated he pulled the console from use and did not give the hotshot as a result.There were no patient complications reported as a result of the alleged issue.The console will be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Device evaluation duplicated the reported complaint condition.The console was disassembled and checked for defects and damage.Fluid intrusion was noticed on the left and right optical encoders and encoder cables.The parts were replaced and the mechanism was reassembled.The fluid intrusion entry point could not be determined so a boot was replaced and resealed.The console then passed the operational verification test.The optical encoders and short cables that were removed from the console exhibited bluish-green corrosion on the encoders from the fluid intrusion.

• 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: 6478200
• Report Number: 1649914-2017-00038
• Device Sequence Number: 1289356
• Product Code: DTR
• UDI-Device Identifier: 20634624521265
• UDI-Public: 20634624521265
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Device Lot Number: 2124
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/28/2017
• Supplement Date Received by Manufacturer: 03/28/2017
• Initial Report FDA Received Date: 04/10/2017
• 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