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

Model Number	5001000
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/08/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital equipment coordinator reported an issue encountered with the mps console during use.The report stated that the console had been intermittently popping the vent valve while delivery cardioplegia.There were no patient complications reported as a result of the alleged event.A field service engineer will travel to the user facility to evaluate the console.
Additional Manufacturer Narrative
The manufacturer's field service engineer (fse) evaluated the mps console at the user facility's site.The reported complaint condition was duplicated.This was most likely attributed to the fluid level sensor, which was replaced.During troubleshooting a water leak was noticed coming from the locking knob.The leak could not be fixed on site so the fse shipped the console back to the manufacturing site for repair.

• Brand Name: MPS CONSOLE
• Common Device Name: CPBP HEAT EXCHANGER
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• MDR Report Key: 6457761
• Report Number: 1649914-2017-00028
• Device Sequence Number: 16288839
• Product Code: DTR
• UDI-Device Identifier: 20634624501007
• UDI-Public: 20634624501007
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K953838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2017

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: 5001000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/08/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2017
• Supplement Report FDA Received Date: 05/02/2017
• 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