MAUDE Adverse Event Report: QUEST MEDICAL INC MPS2 CONSOLE; CPBP HEAT EXCHANGER

Model Number	5201260
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital perfusionist reported an issue encountered with the mps2 console during use.The report stated that the console displayed an error code "additive under delivery." the report stated this occurred throughout the procedure but the staff was to complete the procedure.There were no patient complications reported as a result of the alleged event.The console was returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Evaluation of the console was able to duplicate the error code (259) sc_pcs_ power supply version.The issue was isolated to the pcsa board.Tried another pcsa board, and corrected the error reported.Replaced pcsa board and did temperature and pressure calibration and passed all further testing.

• Brand Name: MPS2 CONSOLE
• Common Device Name: CPBP HEAT EXCHANGER
• Manufacturer (Section D): QUEST MEDICAL INC; one allentown parkway; allen TX 75002
• MDR Report Key: 6619384
• Report Number: 1649914-2017-00045
• Device Sequence Number: 624262
• Product Code: DTR
• UDI-Device Identifier: 20634624521265
• UDI-Public: 20634624521265
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: 5201260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/08/2017
• Supplement Date Received by Manufacturer: 05/08/2017
• Initial Report FDA Received Date: 06/07/2017
• Supplement Report FDA Received Date: 08/10/2017
• 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