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

Model Number 4004203

Device Problems Leak/Splash (1354); No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

There were no patient complications resulting from the alleged incident.An investigation will be conducted and a follow-up medwatch will be submitted if additional information is received.

Event Description

A report received states that the valve leaked from the top during bypass with blood loss less than 100cc.The valve was replaced.No patient complications were reported at this time.

Manufacturer Narrative

The device was evaluated and it functioned as intended.The device is intended to relieve pressure at negative pressure of -150mmhg and positive pressure build up of +340mmhg (avg).Leaking was observed from the pressure relief valve under the hood at approximately 10.01 psi (517.66 mmhg) which is within the acceptable range.A dhr review was conducted and no anomalies were found.

• 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: tosan onosode ; one allentown parkway; allen, TX 75002 ; 9723326338
• MDR Report Key: 7173830
• MDR Text Key: 96847689
• Report Number: 1649914-2018-00010
• Device Sequence Number: 1
• Product Code: DWD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K760894
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 4004203
• Device Lot Number: 054400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1