• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. VALVE, O.P.S BULK, N-S; OVERPRESSURE SAFETY VALVE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TERUMO CARDIOVASCULAR SYSTEMS CORP. VALVE, O.P.S BULK, N-S; OVERPRESSURE SAFETY VALVE Back to Search Results
Model Number LN130B
Device Problem Leak/Splash (1354)
Patient Problem Blood Loss (2597)
Event Date 05/11/2017
Event Type  malfunction  
Manufacturer Narrative
Terumo has not received the device for evaluation; therefore, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.(b)(4).
 
Event Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass procedure, the blood was leaking from the vent valve.Blood loss of 5 cc.Product was not changed out.Procedure was completed successfully.
 
Manufacturer Narrative
This follow-up report is submitted to fda in accord with applicable regulations and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on may 28, 2017.A second supplemental report will be submitted when additional information becomes available.
 
Manufacturer Narrative
This follow-up report is submitted to the fda in accord with applicable regulations.Visual inspection was performed on the returned sample, during which no anomalies were noted, other than dried blood within the valve.Ops valves are subject to a 100% leak test, which includes five different tests the units are run through to ensure there are no leaks and both the umbrellas and duckbills are functioning properly.The returned sample was manually run through each of these tests to determine if the umbrellas were functioning properly; all tests passed.A retention sample from the same product code/lot number combination was run through the same tests and confirmed to pass each of the 5 leak tests.Simulation testing of the ops valve in an aortic root vent line found the ops valve to leak if the vent line was not properly clamped during cardioplegia delivery, and there was possible pressure buildup in the heart causing a positive pressure buildup in the vent line.The positive pressure relief valve then opened to release the pressure, and cause the ops valve to leak.This may have been the cause of the reported leak if the valve was used in the aortic root vent line.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
VALVE, O.P.S BULK, N-S
Type of Device
OVERPRESSURE SAFETY VALVE
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORP.
125 blue ball road
elkton MD 21921
Manufacturer Contact
cathleen hargreaves
125 blue ball road
elkton, MD 21921
8002837866
MDR Report Key6596366
MDR Text Key76158517
Report Number1124841-2017-00099
Device Sequence Number1
Product Code DTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K820297
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 06/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2019
Device Model NumberLN130B
Device Catalogue NumberN/A
Device Lot NumberVA16
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/19/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/11/2017
Initial Date FDA Received05/28/2017
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received06/07/2017
06/22/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/16/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-