MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. SHUNT SENSOR SYS500; BLOOD-GAS MONITOR

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).

• 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 Key: 4317206
• MDR Text Key: 18039539
• Report Number: 1124841-2014-00187
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K972962
• Number of Events Reported: 1
• 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 Date: 02/28/2015
• Device Model Number: CD1510H
• Device Lot Number: RD10K
• Other Device ID Number: (01) 00699753160767
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/13/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 6 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/31/2014
• Initial Date FDA Received: 12/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1