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U.S. Department of Health and Human Services

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

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QUEST MEDICAL, INC. RLV-2100 "B" VACUUM RELIEF VALVE CPBP SUCTION CONTROL DEVICE Back to Search Results
Model Number 4103102
Device Problem Leak/Splash (1354)
Patient Problem No Information (3190)
Event Date 12/02/2015
Event Type  Injury  
Event Description
The foreign distributor reported an issue encountered with the suction valve. They reported that their customer (hospital perfusionist) reported that the valve leaked during use. The valve was returned to the manufacturer for analysis.
 
Manufacturer Narrative
The lot number of the device was not provided nor recorded by the user facility. The device was returned to the manufacturer for evaluation. The device was attached to a roller pump and tested at both high and low speeds, but no leaks were observed. The device was tested a various pressure settings of negative and positive pressures and a leak was observed at a positive pressure of 1012mmhg. This device is designed to provide pressure relief at a negative pressure of -200mmhg and at a positive pressure of <1300mmhg. Visually there was dried/crystallized blood found on the umbrella valve edges. The cause of the reported defect could not be determined. The complaint condition could not be duplicated. 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.
 
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Brand NameRLV-2100 "B" VACUUM RELIEF VALVE
Type of DeviceCPBP 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 Key5339684
MDR Text Key34913958
Report Number1649914-2015-00112
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 health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/23/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number4103102
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2015
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/02/2015
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/02/2016 Patient Sequence Number: 1
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