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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. SHUNT SENSOR SYS500; BLOOD-GAS MONITOR
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TERUMO CARDIOVASCULAR SYSTEMS CORP. SHUNT SENSOR SYS500; BLOOD-GAS MONITOR Back to Search Results
Model Number CDI510H
Device Problem Leak/Splash (1354)
Patient Problem Blood Loss (2597)
Event Date 10/31/2014
Event Type  malfunction  
Event Description
The user facility reported to terumo cardiovascular group that during cardiopulmonary bypass the shunt sensor leaked.The leak was observed to occur at the luer adapter.Less than 1cc of blood loss.Product was changed out.Surgery was completed successfully.
 
Manufacturer Narrative
Terumo has received the actual device for evaluation; however, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is completed and more info becomes available.(b)(4).
 
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Brand Name
SHUNT SENSOR SYS500
Type of Device
BLOOD-GAS MONITOR
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORP.
elkton MD 21921
Manufacturer Contact
robyn o'donnell, manager
125 blue ball rd.
elkton, MD 21921
8002623304
MDR Report Key4321349
MDR Text Key5256190
Report Number1124841-2014-00186
Device Sequence Number1
Product Code DRY
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K972962
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 11/14/2014
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 Date05/31/2015
Device Model NumberCDI510H
Device Lot NumberRF26F
Other Device ID Number(01)00699753160767
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer11/18/2014
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Device Age4 MO
Event Location Hospital
Initial Date Manufacturer Received 11/14/2014
Initial Date FDA Received12/02/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/23/2014
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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