MAUDE Adverse Event Report: QUEST MEDICAL, INC. RLV-2100 B VACUUM RELIEF VALVE CARDIOVASCULAR SUCTION CONTROL VALVE

Model Number 4103202

Device Problem Fluid Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 03/11/2016

Event Type  Injury  

Manufacturer Narrative

There is no sample available for evaluation. The original report included a video of the device in use; however, it provided only a limited view of the tubes and extension lines. From that view, the manufacturer attempted to capture every possible scenario that could result in the reported type of leakage. The purpose of the suction control device is to prevent excessive negative pressures in the ventricle. The product also contains an anti-backflow feature to prevent retrograde flow and a pressure relief valve that vents blood purposely to atmosphere in the event retrograde flow due to operator or installation error. During operation, the product operates under vacuum. Any leak path will result air flow from the atmosphere into the conduit. When flow is near or at zero flow, a slight positive pressure may result and cause blood to leak onto the floor. These valves are designed for pressure relief at a negative pressure of -200mmhg and at a positive pressure <1300mmhg, any time negative or positive pressure exceed these specifications the valve leaks. 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 foreign distributor ((b)(4)) reported an issue encountered by their customer while using the suction control device. This device was sold to the distributor as sterile, bulk shipment for further processing for their customers. The distributor could not determine the exact lot number affected but was able to identify 3 possible lots. The device was discarded by the user and not returned to the distributor or manufacturer for analysis. There was no additional information to be obtained other than the original report. The report had stated that the suction control device had leaked during use, near the end of the procedure. The reported blood loss was approximated to be 50 cc. There were no patient complications reported as a result of the alleged event.

• Brand Name: RLV-2100 B VACUUM RELIEF VALVE
• Type of Device: CARDIOVASCULAR SUCTION CONTROL VALVE
• 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: 5551105
• MDR Text Key: 41995035
• Report Number: 1649914-2016-00012
• 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: distributor,foreign

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 4103202
• Device Lot Number: 047264, 047470, OR 047578
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/11/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/06/2016 Patient Sequence Number: 1