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

Model Number	4103202
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record for the lot was reviewed and no devices were rejected and no specific manufacturing yield issues were reported similar to the reported complaint condition.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 or Problem Description
The distributor reported an issue one of their customers encountered during use of the cardiopulmonary suction control device.The report stated the device leaked from the red vent line of the distributor's custom perfusion pack.The report stated the leak was monitored and the procedure successfully completed with no complications.There were no patient complications reported as a result of the alleged event.The distributor's performance analysis stated their analysis of the device found it leaked at approximately 600 mmhg instead of the specified 1300 mmhg.The device is a cardiopulmonary suction control device sold in bulk, non-sterile form to the distributor for additional processing prior to end-use.The device was returned to the manufacturer for evaluation.

• Brand Name: RLV-2100 VACUUM RELIEF VALVE
• Common Device Name: CARDIOPULMONARY SUCTION CONTROL DEVICE
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• MDR Report Key: 6445082
• Report Number: 1649914-2017-00022
• Device Sequence Number: 13671711
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/27/2017

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: 050848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2017
• Initial Report FDA Received Date: 03/29/2017
• 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