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

Model Number CDI510H

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 12/04/2015

Event Type  malfunction  

Manufacturer Narrative

The actual sample was not returned.Leak testing on the retention sample found the unit to not leak, and the complaint was not confirmed.The failure mode reported could not be recreated; therefore, a definitive root cause could not be determined.According to the complaint description, the location of the leak observed was either at the connection of the housing to the large blue vent cap, or at the weld of the insert to the housing.If the leak originated between the connection of the housing and the large blue vent cap, the most likely root cause is that the cap had not been completely tightened onto the housing prior to use.In order to perform gas calibration prior to use, the blue vent cap must be loosened to allow the gas to flow through the shunt.It is possible that the cap had not been tightened back onto the housing adequately, allowing blood to leak at this connection during use.If the leak had occurred at the weld between the insert and the shunt housing, the following may be the root cause for the issue: when analyzing the trending and geographical location of weld leak complaints, it was noted that about 90% of the weld leak complaints originate from the japanese market.Combining this data with the fact that the japanese market is only 11% of the product sales indicates that something in the shipping and handling process may contribute to the weld leaks.A root cause analysis will be conducted in capa (b)(4) to investigate the shipping and handling conditions and all other possible factors.A review of the device history record revealed no production related anomalies.A definitive root cause was unable to be determined.(b)(4).All available information has been placed on file in quality management for appropriate tracking, trending and follow up.

Event Description

The user facility reported to terumo cardiovascular systems that during cardiopulmonary bypass, blood leaked from the shunt sensor at an unidentified location on the device.2-3cc blood loss.Product was changed out.Surgery was completed successfully without delay.

• Brand Name: SHUNT SENSOR SYS500
• Type of Device: BLOOD GAS MONITOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: robyn o'donnell ; 125 blue ball road; elkton, MD 21921 ; 8002623304
• MDR Report Key: 5323939
• MDR Text Key: 34938425
• Report Number: 1124841-2015-00336
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/23/2015

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: 04/30/2016
• Device Model Number: CDI510H
• Device Lot Number: TF25F
• Other Device ID Number: (01)00699753160767
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2015
• Initial Date FDA Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2015
• 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