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	04/14/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital perfusionist reported an issue encountered with the mps console during use.He stated that during end of case that he heard a loud grinding noise coming from the console.The report stated that the console was in warm mode and a heater/cooler was in use.The perfusionist stated he smelled something coming from the console but continued to use the console to complete the procedure.There were no patient complications reported as a result of the alleged issue.The console was returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Device evaluation found that the circulation motor was seized.The motor was replaced and the unit was processed with no complications.Further evaluation of the circulation motor that was removed found that the rear pump housing was seized onto the drive magnet.This is a result of insufficient water flow through the pump head which is also the root cause of the complaint.When there is insufficient water flow, the pump head heats up and the plastic expands until it rubs against the drive magnet causing the plastic housing to seize to the drive magnet.

• Brand Name: MPS2 CONSOLE
• Common Device Name: CPBP HEAT EXCHANGER
• Manufacturer (Section D): QUEST MEDICAL INC; one allentown parkway; allen 75002
• MDR Report Key: 6566085
• Report Number: 1649914-2017-00042
• Device Sequence Number: 13474454
• Product Code: DTR
• UDI-Device Identifier: 20634624521265
• UDI-Public: 20634624521265
• Combination Product (Y/N): N
• 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,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2017

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: 05/02/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/14/2017
• Supplement Date Received by Manufacturer: 04/14/2017
• Initial Report FDA Received Date: 05/14/2017
• Supplement Report FDA Received Date: 07/23/2017
• 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