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

Model Number 5201260

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Information (3190)

Event Date 05/11/2015

Event Type  malfunction  

Event Description

The foreign (b)(6) hospital reported an issue encountered while using the mps2 console.It was reported that the console display would indicate that the arrest agent was empty when there was actually plenty remaining in the chamber.The perfusionist also stated that the arrest agent display would display erratic readings defaulting then to "zero." this resulted in the customer performing an arrest agent refill when there was a known volume in the pouch.There were no specifics provided regarding patient information.The hospital did not report any patient complications as a result of the alleged issue with the console.The console was returned to the manufacturer for analysis.

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.

Manufacturer Narrative

Device evaluation found that there was evidence of fluid intrusion (residue) on the encoders and short cables.The log data was not retrievable, and the reported complaint condition could not be duplicated.The cause of the complaint could not be definitively determined.

• Brand Name: MPS-2 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
• MDR Report Key: 4825158
• MDR Text Key: 5900997
• Report Number: 1649914-2015-00039
• Device Sequence Number: 1
• Product Code: DTR
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K041979
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2015
• 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: 05/27/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2006
• 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