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

Model Number 5201260

Device Problems Air Leak (1008); Excess Flow or Over-Infusion (1311); Device Displays Incorrect Message (2591)

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

Event Date 08/10/2015

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.It was reported that the console had successfully completed priming, but during delivery of the first dose to arrest the heart the vent valve opened when it shouldn't have and the console displayed the error message "air in the heat exchanger." the perfusionist stated the vent valve remained open which caused him to deliver more cardioplegia than typical.The perfusionist reported the heart was arrested and the staff was able to switch out consoles and resume the procedure.There were no resultant patient complications reported as a result of the alleged malfunction.The console was returned to the manufacturer for evaluation.

Manufacturer Narrative

The fluid level sensor was replaced.The console then passed all functional performance testing and was returned to customer.

• Brand Name: MPS2 MYOCARDIAL PROTECTION SYSTEM
• 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: 5065078
• MDR Text Key: 26004669
• Report Number: 1649914-2015-00060
• Device Sequence Number: 1
• Product Code: DTR
• 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: Followup
• Report Date: 08/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2015
• 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: 08/21/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2015
• 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