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	02/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is currently unknown if the console will be returned for evaluation or if a field service engineer will travel to the facility for evaluation on-site.
Event or Problem Description
The hospital biomedical engineer reported an issue encountered with the mps console during use.The report stated that the console displayed an error code for "rt motor stuck at bottom" at the end of the procedure during the last warm dose of cardioplegia.This report is filed out of abundance of precaution because the complaint details did not specify exactly when the alleged issue occurred; that is if the patient was still on bypass or not.There were no patient complications reported as a result of the alleged event.It is unknown if the console will return to the manufacturer for evaluation.
Additional Manufacturer Narrative
The console was not returned to the manufacturer for evaluation nor was it repaired by the manufacturer in the field.The customer returned the pcb component to the manufacturer for replacement.The customer reported that the replacement pcb worked on 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: 6445100
• Report Number: 1649914-2017-00024
• Device Sequence Number: 1378247
• Product Code: DTR
• UDI-Device Identifier: 20634624521265
• UDI-Public: 20634624521265
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K041979
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2017

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 the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/27/2017
• Supplement Date Received by Manufacturer: 02/27/2017
• Initial Report FDA Received Date: 03/29/2017
• Supplement Report FDA Received Date: 08/06/2017
• 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