FDA.reportPublic FDA data

MAUDE MDR 5250312

MDR report key
5250312
Report number
1649914-2015-00101
Event key
0
Event type
3
Date of event
2015-10-28
Date received
2015-11-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MRS. AMY CLENDENING-WHEELER
Address
ONE ALLENTOWN PARKWAY ALLEN TX 75002 US
Phone
972-972-9723
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1RLV 2100-B SUCTION CONTROL DEVICESUCTION CONTROL VALVEQUEST MEDICAL, INC.DWD41031020483215J07Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-11-2501. R

Event Narratives#

N

Patient 1

THERE WERE NO OTHER DEVICES REMAINING IN INVENTORY FOR ANALYSIS. THE DEVICE SAMPLES RETURNED FOR EVALUATION PASSED ALL FUNCTIONAL AND PERFORMANCE TESTING. THE COMPLAINT COULD NOT BE CONFIRMED. THE PURPOSE OF THE VALVE IS TO PREVENT EXCESSIVE NEGATIVE PRESSURE IN THE VENTRICLE. IT CONTAINS AN ANTI-BACKFLOW FEATURE TO PREVENT RETROGRADE FLOW, AND A PRESSURE RELIEF VALVE THAT VENTS BLOOD IN THE EVENT OF RETROGRADE FLOW DUE TO OPERATOR OR INSTALLATION ERROR. 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.

D

Patient 1

THE HOSPITAL STERILE PROCESSOR REPORTED FOR THE PERFUSIONIST THAT THERE WAS AN ISSUE ENCOUNTERED WHILE USING THE SUCTION CONTROL DEVICES. THE REPORT STATED THAT BOTH SUCTION VALVES LEAKED DURING THE PROCEDURE. FOLLOW UP WITH THE COMPLAINANT FOUND THAT THE VOLUME OF BLOOD LOSS WAS NOT RECORDED. THE VALVES WERE CHANGED OUT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE VALVES WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS.