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

Model Number 4103202

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/24/2017

Event Type  Injury  

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 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 in the white 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 400 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
• Type of Device: CARDIOPULMONARY 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: 6445076
• MDR Text Key: 71207774
• Report Number: 1649914-2017-00021
• Device Sequence Number: 1
• Product Code: DWD
• UDI-Device Identifier: 20634624413225
• UDI-Public: 20634624413225
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K864503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Other
• Device Model Number: 4103202
• Device Lot Number: 050538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/27/2017
• Initial Date FDA Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2016
• 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