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

Model Number CDI510H

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 07/14/2017

Event Type  malfunction  

Manufacturer Narrative

Terumo has received the device for evaluation; however, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.(b)(4).

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, the leakage was found at the part of the large blue luer cap.No patient involvement as this occurred during prime, product was changed out, procedure was completed successfully,.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on august 4, 2017.The sample was visually inspected for any anomalies, during which no issues were noted that would lead to a leak in the part.The unit was then gradually pressurized in a water bath to roughly 1000mmhg for 30 seconds, being sure that all caps and connections were tightened and closed.No leaks were observed during the test.It is possible that during setup of the circuit, the connections made with the shunt sensor were not completely tightened or closed, causing them to leak.Another possibility is that after gas calibration, when the large blue vent cap was loosened, it had not been retightened prior to use in the line, causing a leak from the cap.The customer reported that the leak occurred at the large blue cap; therefore, this is the most likely cause of the reported leak.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: SHUNT SENSOR SYS500
• Type of Device: BLOOD GAS MONITOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6766530
• MDR Text Key: 81818976
• Report Number: 1124841-2017-00163
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/25/2017

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: 12/31/2017
• Device Model Number: CDI510H
• Device Catalogue Number: N/A
• Device Lot Number: VA16L
• Other Device ID Number: (01)00699753160767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/14/2017
• Initial Date FDA Received: 08/04/2017
• Supplement Dates Manufacturer Received: 08/10/2017
• Supplement Dates FDA Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2017
• 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