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

Model Number	4103202
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	08/22/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample was attached to 48" water head height which is approximately 1.73 psi (89.76mmhg), it did not leak at the umbrella valve.The sample was attached to the roller pump and tested at low speed and high speed.No leak was seen.Then the sample was tested at different pressure settings of negative and positive pressures, the valve leaked at positive pressure of 1310mmhg.These valves are designed for pressure relief at a negative pressure of -200mmhg and at a positive pressure <1300mmhg.The roller pump was ran to test for retrograde flow, the valve leaked at the pressure relief band as it is designed to do so.Evaluation in progress, not yet complete.
Event or Problem Description
The foreign distributor (b)(6) reported an issue encountered with the use of the cardiopulmonary suction control device from one of their customers.The report stated that the device leaked for approximately 2-3 minutes during use.The report stated the device was removed from use and a different one was used to complete the procedure.The patient was given a transfusion to address the blood loss (volume not provided) with no patient complications reported as a result of the alleged issue.The device was returned to the manufacturer for evaluation.The device is a suction control device sold in bulk non-sterile form to the distributor for additional processing prior to end-use.
Additional Manufacturer Narrative
No visual or functional anomalies were found with the device sample.The valve met specification.The device history record for the applicable lot of product did not show any manufacturing or quality concerns similar to the reported complaint condition.

• Brand Name: RLV-2100 B VACUUM RELIEF VALVE
• Common Device Name: SUCTION CONTROL VALVE
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• MDR Report Key: 5963860
• Report Number: 1649914-2016-00047
• Device Sequence Number: 660287
• Product Code: DWD
• UDI-Device Identifier: 20634624413225
• UDI-Public: 20634624413225
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K864503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: 4103202
• Device Lot Number: 050538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/20/2016
• Supplement Report FDA Received Date: 09/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention