MAUDE Adverse Event Report: QUEST MEDICAL, INC. MPS-2 CONSOLE; CPBP HEAT EXCHANGER

Model Number	5202260
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/24/2016
Type of Reportable Event	Malfunction
Event or Problem Description
The international distributor ((b)(6)) reported an issue encountered by one of their customers with the mps-2 console.The report stated that the console in use was displaying 3 different error codes during a recent procedure (exact date not provided).The codes were "ec 203/motor stuck at bottom," "arrest is disabled," "arrest pump error, proceed without pump." attempts to obtain additional information regarding specific details on the alleged event were unsuccessful.The facility has 2 consoles and they did not identify which console was involved in the complaint.At this time it is unknown if the console will be returned to the manufacturer for analysis.There were no patient complications reported as a result of the alleged event.See also manufacturer report 1649914-2016-00011 for similar incident which occurred at another facility/customer of the distributor.
Additional Manufacturer Narrative
The manufacturer spoke with the biomedical engineer/representative at the facility in kuwait who said the alleged issue with the consoles were fixed and the consoles are in use.The facility stated that they are planning on sending their biomedical engineer to the manufacturer's site for additional training including trouble-shooting guidance for similar complaint conditions in the future.The consoles are not returning to the manufacturer for evaluation.

• Brand Name: MPS-2 CONSOLE
• Common Device Name: CPBP HEAT EXCHANGER
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• MDR Report Key: 5520910
• Report Number: 1649914-2016-00013
• Device Sequence Number: 309404
• Product Code: DTR
• UDI-Device Identifier: 20634624522262
• UDI-Public: 20634624522262
• Combination Product (Y/N): N
• Initial Reporter Country: KU
• PMA/510(K) Number: K041979
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2016

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: 5202260
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/24/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/23/2016
• Supplement Report FDA Received Date: 05/19/2016
• 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