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

Model Number	5001000
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/20/2017
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 really low, and sometimes zero, pressure during delivery.There were no patient complications reported as a result of the alleged issue.The console will be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Evaluation of the console found that the complaint condition was duplicated.The console showed really low pressures when flowing and alarmed ec 216 "high inlet pressure" when priming.The console was opened and checked for defects and damage.During the investigation, the fse noticed the system pressure sensor had been damaged.Someone had pulled the sensor cover off and that action pulled the silicone off the sensor.A new sensor cover had been put on top of the damaged sensor and it looked ok but was defective and caused low pressure readings.A new pressure transducer was put on the console and a pressure calibration was done.

• Brand Name: MPS CONSOLE
• Common Device Name: CPBP HEAT EXCHANGER
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• MDR Report Key: 6574542
• Report Number: 1649914-2017-00043
• Device Sequence Number: 1134351
• Product Code: DTR
• UDI-Device Identifier: 20634624501007
• UDI-Public: 20634624501007
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2017

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: 5001000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/20/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2017
• Supplement Report FDA Received Date: 06/22/2017
• 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