MAUDE Adverse Event Report: QUEST MEDICAL, INC. RLV-2100 "B" VACUUM RELIEF VALVE; CPBP SUCTION CONTROL DEVICE

Model Number 4103102

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 12/02/2015

Event Type  Injury  

Event Description

The foreign distributor reported an issue encountered with the suction valve.They reported that their customer (hospital perfusionist) reported that the valve leaked during use.The valve was returned to the manufacturer for analysis.

Manufacturer Narrative

The lot number of the device was not provided nor recorded by the user facility.The device was returned to the manufacturer for evaluation.The device was attached to a roller pump and tested at both high and low speeds, but no leaks were observed.The device was tested a various pressure settings of negative and positive pressures and a leak was observed at a positive pressure of 1012mmhg.This device is designed to provide pressure relief at a negative pressure of -200mmhg and at a positive pressure of <1300mmhg.Visually there was dried/crystallized blood found on the umbrella valve edges.The cause of the reported defect could not be determined.The complaint condition could not be duplicated.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.

• Brand Name: RLV-2100 "B" 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: 5339684
• MDR Text Key: 34913958
• Report Number: 1649914-2015-00112
• Device Sequence Number: 1
• Product Code: DWD
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: Initial,Followup
• Report Date: 12/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 4103102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/02/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention