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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

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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 03/13/2017
Event Type  malfunction  
Manufacturer Narrative
Terumo has received the device for evaluation; however, 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).Results: results pending completion of evaluation.Conclusions: conclusion not yet available-evaluation in progress.
 
Event Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the vent valve never worked properly.The customer was able to pull some volume through the valve and then stopped.When it started the full volume again, it squirted blood for approximately 2cc.Product was 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 april 6, 2017.(b)(4).Visual inspection was performed on the returned sample, during which it was found that the negative umbrella was not in its proper place, as not all of the edges were outside of the housing.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 following test was performed: program 1: the sample was connected in a circular circuit and pressurized with a syringe to 3.5psi while submerged under water to test the body of the ops for leaks.A leak was seen from the negative umbrella, and the valve was not able to hold pressure.All units are also 100% visually inspected both during the leak testing step and during packaging.It is possible that the unit was subjected to damage at some point after final release causing the negative umbrella to not be seated properly.As this event occurred during cpb, and not prime, it is possible for the valve to have been hit during use causing the damage to the umbrella valve.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
 
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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 Key6463307
MDR Text Key72394344
Report Number1124841-2017-00051
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
Report Date 05/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2019
Device Model NumberLN130B
Device Catalogue NumberN/A
Device Lot NumberUD14
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/16/2017
Initial Date FDA Received04/06/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/10/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/14/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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