• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

QUEST MEDICAL, INC. RLV-2100 B VACUUM RELIEF VALVE CARDIOVASCULAR SUCTION CONTROL VALVE Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRLV-2100 B VACUUM RELIEF VALVE
Type of DeviceCARDIOVASCULAR 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 Key5551105
MDR Text Key41995035
Report Number1649914-2016-00012
Device Sequence Number1
Product Code DWD
Combination Product (y/n)N
Reporter Country CodeSN
Number of Events Reported1
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 Received04/06/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model Number4103202
Device Lot Number047264, 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 Received03/11/2016
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
-
-