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

Model Number	5201260
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/01/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital biomedical engineer reported an issue the perfusionist encountered with the mps console during use.The report stated that the console displayed an alarm code for "unknown temperature" and would not heat.The report did not state at what point during priming or the procedure the alleged issue occurred.Initial troubleshooting indicated the problem may be due to a problematic ir sensor causing an inaccurate temperature reading.The console was returned to the manufacturer for evaluation.There were no patient complications reported as a result of the alleged issue.
Additional Manufacturer Narrative
The console was received and the reported complaint was not duplicated.The customer reported the console would not heat.Log data showed the circulation system was turned off and then warm delivery was selected which would have caused the console not to heat.Review of log data found that while delivering cold cardioplegia, the ir temperature and h20 temperature were off by more than 15 degrees.The console was opened and checked for defects and damage.The console was turned on and the room temperature was 20 degrees c and the console delivery temp (ir) display showed it to be 37 degrees which is not accurate.The ir sensor was suspect and replaced as a result of the investigation.After replacement and calibration of the ir temp sensor, the condition was no longer duplicated.Console 2203 was reassembled and passed all functional 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: 6455540
• Report Number: 1649914-2017-00026
• Device Sequence Number: 591273
• Product Code: DTR
• UDI-Device Identifier: 20634624521265
• UDI-Public: 20634624521265
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2017

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/06/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2017
• 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