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

Model Number	R5201260
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to return to quest medical for evaluation.A follow-up medwatch will be submitted if additional information becomes available.
Event or Problem Description
A report was received regarding an alleged issue which occurred with the mps 2 console.The report states that the console displayed ec 225 and issued the following alarms: insufficient blood inlet and excessive blood inlet.No patient complications resulted from the alleged issue.
Additional Manufacturer Narrative
The device evaluation showed fluid intrusion on the left pump optical encoder and back out of a pin.The source of the fluid intrusion is unknown.The encoder and pin were replaced and the console passed all operational verification tests.Quest medical will continue to monitor complaints for trend.

• 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: 7600906
• Report Number: 1649914-2018-00057
• Device Sequence Number: 1754224
• Product Code: DTR
• UDI-Device Identifier: 20634624521265
• UDI-Public: 20634624521265
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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,Followup
• Report Date (Section B): 11/26/2018

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 Health Care Professional
• Device Model Number: R5201260
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/04/2018
• Supplement Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 06/14/2018
• Supplement Report FDA Received Date: 11/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1