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	05/22/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital biomedical engineer reported an issue with the mps2 console during use.The report stated that the perfusion department had issues with the console popping the vent valve during more than one procedure.The report stated that changing the delivery set did not cause the issue to stop.There were no patient complications reported as a result of the alleged issue.
Additional Manufacturer Narrative
Follow-up with the complainant found that the facility had not returned the console.The console was still in use at the facility with no further issues occurring.Initial medwatch erroneously indicated hospitalization as an outcome attributed to adverse event of the form.This was a mistake as there were no reported patient complications associated with the complaint.

• 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: 6652733
• Report Number: 1649914-2017-00047
• Device Sequence Number: 1285283
• Product Code: DTR
• UDI-Device Identifier: 20634624521265
• UDI-Public: 20634624521265
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2017

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: 05/22/2017
• Supplement Date Received by Manufacturer: 05/22/2017
• Initial Report FDA Received Date: 06/19/2017
• Supplement Report FDA Received Date: 11/08/2017
• 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: Hospitalization