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	05/26/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital perfusionist reported an issue encountered with the mps 2 console during use.The report stated the console primed fine but suddenly started displaying over pressure alarms and would shut off flow.The report stated the perfusionist wanted the console to be evaluated.There were no patient complications reported as a result of the alleged event.The console was returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Device evaluation found the reported complaint condition could not be duplicated, but the related error code was confirmed in log data.Further investigation found that the console displays inadequate fill alarms on the right pumping chamber when flowing at 250 ml.The console's red door was opened and the field service engineer found that the pin and roller on the right side had dislodged.The pin and roller were reinstalled with the correct hardware and the inadequate alarms resolved.The console was reassembled and passed all functional testing.

• 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: 6666117
• Report Number: 1649914-2017-00051
• Device Sequence Number: 13640837
• Product Code: DTR
• UDI-Device Identifier: 20634624521265
• UDI-Public: 20634624521265
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2017

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: 06/09/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/26/2017
• Supplement Date Received by Manufacturer: 05/26/2017
• Initial Report FDA Received Date: 06/25/2017
• 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