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

Model Number 5201260

Device Problems Failure to Prime (1492); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/10/2016

Event Type  malfunction  

Manufacturer Narrative

Quest medical, inc.Has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Quest medical, inc.Defers to the patient's physician regarding medical history.

Event Description

The hospital perfusionist reported an issue encountered with the mps2 console during use.He reported a priming issue with the console that he was able to work through, but the issue occurred again right before placing the patient on bypass.The report stated the console displayed "air in the hex" multiple times and the perfusionist observed fluid in the delivery line that would suck back to the heat exchanger.The perfusionist said he double and triple-checked the delivery and vent line for proper installation.The report stated the console was removed from use and another console was used to complete the procedure.There were no patient complications reported as a result of the alleged event.The console was returned to the manufacturer for analysis.

Manufacturer Narrative

The complaint sample was received and evaluated.The alleged complaint condition could not be duplicated.There were no issues found with the console which passed all functional testing.Log data was reviewed which found an error code for an unrelated issue (ante valve position fail) so that component was replaced as a precautionary measure.

• Brand Name: MPS2 MYOCARDIAL PROTECTION SYSTEM CONSOLE
• Type of Device: CPBP HEAT EXCHANGER
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• Manufacturer (Section G): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• Manufacturer Contact: amy clendening-wheeler ; one allentown parkway; allen, TX 75002 ; 9723326338
• MDR Report Key: 5480528
• MDR Text Key: 40031944
• Report Number: 1649914-2016-00005
• Device Sequence Number: 1
• Product Code: DTR
• UDI-Device Identifier: 20634624521265
• UDI-Public: 20634624521265
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041979
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 5201260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention