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	08/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The console was received and the reported error code was found in the log data but was not repeatable.Evaluation of the console showed signs of fluid intrusion in the encoder.The encoder and cable were replaced and the console completed processing with no complications.The root cause of the fluid intrusion is unknown.
Event or Problem Description
The hospital biomedical engineer reported for perfusion that an issue was encountered with the mps2 console during use.The report stated that the perfusionist was giving the initial dose and got an alarm message.The perfusionist stated that she kept receiving the alarm after powering off and back on.The perfusionist stated she used another console to complete the procedure.There were no patient complications reported as a result of the alleged issue.The console is expected to return to the manufacturer for evaluation.

• 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: 7011846
• Report Number: 1649914-2017-00070
• Device Sequence Number: 11118741
• Product Code: DTR
• UDI-Device Identifier: 20634624521265
• UDI-Public: 20634624521265
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K041979
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 11/08/2017

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?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2017
• Initial 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: Required Intervention