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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUEST MEDICAL, INC. RLV 2100 "B" SUCTION CONTROL DEVICE CARDIOVASCULAR SUCTION CONTROL DEVICE

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QUEST MEDICAL, INC. RLV 2100 "B" SUCTION CONTROL DEVICE CARDIOVASCULAR SUCTION CONTROL DEVICE Back to Search Results
Model Number 4103102
Device Problem Fluid Leak (1250)
Patient Problem Blood Loss (2597)
Event Date 07/01/2015
Event Type  Injury  
Manufacturer Narrative
The reported complaint condition could not be confirmed. The sample (lot unknown) was attached to a roller pump and ran at both low and high speeds. No leaks were observed. The testing was repeated at various pressures as well. The device continued to perform as expected.
 
Event Description
The international distributor ((b)(4)) reported an issue encountered with the suction control device during use. They stated their customer reported that during a procedure in (b)(6) 2015, when blood flowed through the pressure relief valve case, blood was observed to be leaking from it. They said approximately 10 mls of blood leaked before it was noticed. It was replaced by another valve and the procedure resumed with no danger to patient. The device lot number was not recorded or provided. The device was returned to the manufacturer for evaluation.
 
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Brand NameRLV 2100 "B" SUCTION CONTROL DEVICE
Type of DeviceCARDIOVASCULAR 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 Key5382692
MDR Text Key36492263
Report Number1649914-2015-00121
Device Sequence Number1
Product Code DWD
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
K864503
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial
Report Date 11/20/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model Number4103102
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/01/2015
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/20/2015
Was Device Evaluated by Manufacturer? Yes
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: 01/21/2016 Patient Sequence Number: 1
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