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	05/26/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital perfusionist reported an issue encountered while using the mps-2 console.The report stated the console was displaying an "arrest agent pump occluded" alarm and the console was also not delivering the proper amount of potassium.The report stated a call with the manufacturer recommended to him to replace his arrest pouch but at the time of the call the procedure had already completed.The perfusionist stated he removed the arrest pouch to see if there were any signs of occlusions and said he had to "squeeze very hard to get any fluid to flow out." the perfusionist requested to have the console (serial number not provided) checked out onsite by a field service engineer.There was no information on whether or not the alleged issue caused any patient complications.
Additional Manufacturer Narrative
Evaluation of the console included a flow test and complete wet lab.The console was found to be operating normally, within all designed parameters and specifications.The pump was primed 10 times without incident.The arrest and additive pouches were filled with saline and they emptied properly during the course of the wet lab.No defect was found and the complaint condition could not be repeated.

• 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: 6666113
• Report Number: 1649914-2017-00050
• Device Sequence Number: 750521
• 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: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2017

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: 05/26/2017
• Supplement Date Received by Manufacturer: 05/26/2017
• Initial Report FDA Received Date: 06/25/2017
• Supplement Report FDA Received Date: 08/10/2017
• 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