MAUDE Adverse Event Report: QUEST MEDICAL, INC. MYOCARDIAL PROTECTION SYSTEM CONSOLE; CPBP HEAT EXCHANGER

Model Number	5001000
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Quest medical, inc.Has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Quest medical, inc.Defers to the patient's physician regarding medical history.
Event or Problem Description
The hospital biomedical engineer reported an issue with the mps console during use.He reported for perfusion that the console would repeatedly display an error code and would open the vent valve during cardioplegia delivery.The report stated that the console was used to complete the procedure with the perfusionist manually clamping the vent line closed.There were no patient complications reported as a result of the alleged issue.The console will be evaluated by a field service engineer.
Additional Manufacturer Narrative
A field service engineer evaluated the console at the complainant's facility.The console data log confirmed the alleged error code.The fluid level sensor in this 13 year old console was found to be faulty.The sensor was replaced and the console released for use.

• Brand Name: MYOCARDIAL PROTECTION SYSTEM CONSOLE
• Common Device Name: CPBP HEAT EXCHANGER
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• MDR Report Key: 5950956
• Report Number: 1649914-2016-00046
• Device Sequence Number: 660895
• 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: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2016

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: 08/16/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/14/2016
• Supplement Report FDA Received Date: 11/08/2016
• 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