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

Model Number	5201260
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/04/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital perfusionist reported an issue he encountered with the mps console during use.He stated that the console was displaying an error code for "air in heat exchanger." the manufacturer's field service engineer (fse) was onsite and verified the occurrence of the error code in the console's log data.The fse was unable to duplicate the issue during a wet lab while at the facility.The fse replaced the fluid level sensor as a preventive measure.

• Brand Name: MPS 2 CONSOLE
• Common Device Name: CPBP HEAT EXHANGER
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• MDR Report Key: 6536036
• Report Number: 1649914-2017-00041
• Device Sequence Number: 13640729
• Product Code: DTR
• UDI-Device Identifier: 20634624521265
• UDI-Public: 20634624521265
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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
• Report Date (Section B): 04/04/2017

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2017
• Initial Report FDA Received Date: 05/01/2017
• 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