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

Model Number CDI510H

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 11/14/2017

Event Type  malfunction  

Manufacturer Narrative

Terumo has not received the device for evaluation; therefore, 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.For this reason, terumo references evaluation conclusion.(b)(4).Results: results pending completion of evaluation.Conclusions: conclusion not yet available-evaluation in progress.

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, the shunt sensor leaked.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 december 7, 2017.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations.The returned sample was visually inspected for any anomalies, no white cap, no sparger and no buffer were present upon receiving.Upon closer look at the large blue vent cap, some crystallized white residue was noted between the threads.The large blue vent cap was found stuck and was not able to be tightened or loosened.The returned sample was leak tested by connecting with manometer and syringe, submerged and pressurized with air to around 406 mmhg, when it started to leak.After removing from the water bath, it was observed that the white residue was dissolved.An attempt to tighten the large luer vent cap, it was able to tightened up to half thread.It was leak tested again, pressurized up to 1023 mmhg for 30 seconds and no leaks were observed.Three samples from the 13 unopened units that were returned from the customer were visually inspected, leak tested and pressurized > 1000mmhg for 30 seconds.No anomalies or leaks were observed.The root cause for this event was determined as the large blue vent cap was not fully tightened either during setup of the circuit or after the gas calibration, when the large blue vent cap was loosened, it had not been retightened fully prior to use in the line, causing a leak from the cap.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: 7094932
• MDR Text Key: 94284273
• Report Number: 1124841-2017-00246
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: CDI510H
• Device Catalogue Number: N/A
• Device Lot Number: VM10CXX
• Other Device ID Number: (01)00699753160767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2017
• 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