MAUDE Adverse Event Report: QUEST MEDICAL, INC. MPS BACK-UP SYSTEM; CARDIOPLEGIA DELIVERY SYSTEM

Model Number 5001021

Device Problem Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/21/2018

Event Type  malfunction  

Manufacturer Narrative

The device will be evaluated and a follow up medwatch will be submitted when additional information becomes available.

Event Description

During an in-service training by a quest medical representative at (b)(6) medical center, the mps back up system was found to have failed to maintain forward flow.Upon inspection of the device, it was discovered that the blood inlet channel was permanently shut off by the spring loaded valve, causing the delivery failure.The device was not used in surgery and there were no patient complications resulting from the issue.

Manufacturer Narrative

The device was received and the complaint condition was confirmed.The root cause of the issue was incorrect installation of the inlet valves.The inlet valves were reconfigured correctly and the device was calibrated.The device was tested and it passed all functional testing.The device was tested and it passed all functional testing.As a corrective action, the manufacturing process work instruction was revised to include specifications on the inlet valve orientation.

• Brand Name: MPS BACK-UP SYSTEM
• Type of Device: CARDIOPLEGIA DELIVERY SYSTEM
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• Manufacturer Contact: one allentown parkway; allen, TX 75002
• MDR Report Key: 7394296
• MDR Text Key: 104543653
• Report Number: 1649914-2018-00032
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: 5001021
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1