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U.S. Department of Health and Human Services

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

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QUEST MEDICAL, INC. RLV-2100 VACUUM RELIEF VALVE CARDIOPULMONARY SUCTION CONTROL DEVICE Back to Search Results
Model Number 4103202
Device Problems Suction Problem (2170); Difficult to Open or Close (2921); Pressure Problem (3012)
Patient Problem Blood Loss (2597)
Event Date 10/17/2016
Event Type  Injury  
Manufacturer Narrative
There are no more devices of the same lot remaining in inventory for evaluation. 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 was part of a "sucker line", a negative pressure line used during an ecmo procedure. The report stated that the one-way valve was stuck open, and to resolve the issue a cap was placed on the negative pressure release and another valve was placed proximal to the open valve. The report stated that blood was lost that required a blood transfusion to the patient and an acute pressure drop was observed as a result of the alleged event. The report was completed and no further patient impact was reported. The device was discarded by the end-user and not returned to the distributor or manufacturer for evaluation. The device is a cardiopulmonary suction control device sold in bulk, non-sterile form to the distributor for additional processing prior to end-use.
 
Manufacturer Narrative
The device was not returned to the manufacturer for evaluation. There were no more devices of the same lot remaining in inventory for evaluation. 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.
 
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Brand NameRLV-2100 VACUUM RELIEF VALVE
Type of DeviceCARDIOPULMONARY 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 Key6100637
MDR Text Key59835818
Report Number1649914-2016-00055
Device Sequence Number1
Product Code DWD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K864503
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model Number4103202
Device Lot Number050562
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/18/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/26/2016
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: 11/14/2016 Patient Sequence Number: 1
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