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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 No Known Impact Or Consequence To Patient (2692)
Event Date 04/12/2017
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 prior to cardiopulmonary bypass, during prime, the customer has cut out one way valves from tubing packs.It leaked when tested.No known impact or consequence to the patient.It is unknown if the product was changed out.Procedure was completed successfully.
 
Manufacturer Narrative
The sample was not returned for evaluation, and the lot number was not provided; therefore, a complete investigation was not able to be conducted and the root cause could not be determined.All ops valves are subjected to a 100% leak test that undergoes 5 separate programs to test that each component in the valve is functioning properly.These units are also 100% visually inspected both during the leak testing step and during packaging.It is possible that damage occurred to the device at some point after manufacture, causing the part to leak during use.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 Key6546116
MDR Text Key74498840
Report Number1124841-2017-00073
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 05/18/2017
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 Model NumberLN130B
Device Catalogue NumberN/A
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/14/2017
Initial Date FDA Received05/04/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/18/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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