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	03/03/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital perfusionist reported an issue encountered with the mps console during use.The report stated that the console displayed an error code for "air in the heat exchanger." the report stated the alleged issue has been occurring intermittently.The perfusionist stated that he unlocks the delivery set and resets the heat exchanger when the alarm occurs and this resolves the issue.There were no patient complications reported as a result of the alleged event.The console remains in use, and a field service engineer will travel to the facility to evaluate the console.
Additional Manufacturer Narrative
Device evaluation found that the contact patch on the fluid level sensor was very poor when the console went through priming steps.The sensor was replaced and no further problems were found with the console.

• 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: 6451859
• Report Number: 1649914-2017-00025
• Device Sequence Number: 591088
• Product Code: DTR
• UDI-Device Identifier: 20634624521265
• UDI-Public: 20634624521265
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 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): FDA Requested
• Initial Date Received by Manufacturer: 03/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/02/2017
• Supplement Report FDA Received Date: 04/05/2017
• 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