MAUDE Adverse Event Report: QUEST MEDICAL, INC. VRV-II VACUUM RELIEF VALVE CPBP SUCTION CONTROL DEVICE

Model Number 4003203

Device Problems Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964)

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

Event Date 10/28/2016

Event Type  malfunction  

Manufacturer Narrative

The complaint sample was visually inspected with no anomalies found. To simulate the reported complaint condition, the valve was connected to heise gauge and tested at roller pump speed of 0. 5l/min, 1l/min and 2l/min. At all speeds the valve opened at negative pressure of 149mmhg and positive pressure of 342mmhg. The reported complaint condition could not be duplicated. The device history records for the applicable lot of product were reviewed and the inspection report showed that no defect was found and rejected and no specific manufacturing yield issue was reported similar to this complaint condition. 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 international distributor ((b)(4)) reported an issue encountered by the customer when using the vacuum relief valve. The report stated that the valve "wouldn't allow air through to provide pressure relief and blood flow through was poor". Follow-up with the complainant found that they removed the device from use and replaced it with another. There was no additional blood loss from the usual the change out of valve prolonged the procedure by approximately 5 minutes. There were no patient complications reported as a result of the alleged issue.

• Brand Name: VRV-II VACUUM RELIEF VALVE
• Type of Device: CPBP SUCTION CONTROL DEVICE
• 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: 6128194
• MDR Text Key: 61198081
• Report Number: 1649914-2016-00063
• Device Sequence Number: 1
• Product Code: DWD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K760894
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 4003203
• Device Lot Number: 050044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2016
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/27/2016 Patient Sequence Number: 1