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

Model Number 5201260

Device Problems Failure to Prime (1492); Device Displays Incorrect Message (2591)

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

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 mps console.He reported that the console displayed the "stuck key" alarm during priming of the system and while delivering cardioplegia to the patient.The perfusionist also stated there was an unknown pressure alarm that displayed throughout the procedure as well.The report stated the same console was used throughout the procedure with no patient complications reported as a result of the alleged event.The report did not indicate at what point during the procedure the alleged issues occurred.

Manufacturer Narrative

The console was evaluated by a field service technician.It was opened and checked for any signs of damage or defects, but none were found.The complaint of "stuck key" could not be duplicated; however, review of the log data confirmed it had occurred.It is likely that the alarm was due to the user selecting ante grade source pressure as being an external sensor but not having a sensor plugged into the back of the mps console.

• Brand Name: MYOCARDIAL PROTECTION SYSTEM MPS 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: 5250176
• MDR Text Key: 32356022
• Report Number: 1649914-2015-00102
• 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: 11/17/2015

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
• Device Operator: Other
• Device Model Number: 5201260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/26/2015
• Initial Date FDA Received: 11/25/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/14/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/06/2012
• 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