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

Model Number CDI510H

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 11/18/2014

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 sensor location of the unit.Once the pump was initiated, there was a flow rate of 3.6 l/min, and the blood began to leak, there was a blood loss of less than 10ml.The user stopped using the affected shunt sensor and completed the surgery successfully without the use of a shunt sensor.

Manufacturer Narrative

Terumo has not received the actual device for eval; therefore, the investigation has yet to be completed.Terumo plans on submitting a follow up report when the investigation is complete and more info becomes available.(b)(4).Conclusion: conclusion not yet available - eval in progress.Product code: (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'donnel, quality mgr ; 125 blue ball rd.; elkton, MD 21921 ; 8002623304
• MDR Report Key: 4344524
• MDR Text Key: 5205066
• Report Number: 1124841-2014-00191
• 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: 11/20/2014

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: 05/31/2015
• Device Model Number: CDI510H
• Device Lot Number: RF26H
• Other Device ID Number: (01)00699753160767
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 5 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/20/2014
• Initial Date FDA Received: 12/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1