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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 CD1510H
Device Problem Leak/Splash (1354)
Patient Problem No Patient Involvement (2645)
Event Date 10/28/2014
Event Type  malfunction  
Event Description
The user facility reported to terumo cardiovascular systems corporation that prior to cardiopulmonary bypass, during setup, the shunt sensor experienced several calibration errors.This event was initially determined to be non-reportable.After receipt and eval of the actual sample, it was discovered that the shunt sensor leaked at the weld which caused the calibration errors.This eval discovery was found on (b)(6) 2014.No pt involvement as this occurred during setup.Product was changed out.Surgery was successfully completed.
 
Manufacturer Narrative
Upon eval of the device, the complaint was confirmed.The complaint sample was returned and visually inspected.The initial attempts at calibrating the actual sample were met with errors.The unit was placed into a blood circuit to compare the outputs with the values measured by a blood-gas analyzer.During blood circulation, it was noticed that the shunt sensor was leaking.The calibration errors were due to the leak in the weld area being gross enough to cause a calibration failure.A review of the device history revealed no anomalies which would contribute to a leak.This unit was sufficiently cured and sealed to pass through a 100% leak test in-process.The root cause was identified to be shipping and handling paired with a decrease in mechanical integrity.(b)(4).
 
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Brand Name
SHUNT SENSOR SYS500
Type of Device
BLOOD-GAS MONITOR
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORP.
125 blue ball rd.
elkton MD 21921
Manufacturer Contact
robyn o'donnell, quality mgr
125 blue ball rd.
elkton, MD 21921
8002623304
MDR Report Key4317206
MDR Text Key18039539
Report Number1124841-2014-00187
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 10/31/2014
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 Date02/28/2015
Device Model NumberCD1510H
Device Lot NumberRD10K
Other Device ID Number(01) 00699753160767
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer11/13/2014
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Device Age6 MO
Event Location Hospital
Initial Date Manufacturer Received 10/31/2014
Initial Date FDA Received12/03/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/07/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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