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 Known Impact Or Consequence To Patient (2692)

Event Date 05/15/2018

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.(b)(4).

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the shunt sensor leaked.*no known impact or consequence to patient.*there was a blood loss; however the amount is still unknown.*it is unknown if the 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 june 08, 2018.(b)(4).The actual sample was not returned and the affected lot number was not provided; therefore, a thorough investigation could not be performed and a definitive root cause could not be determined.Similar complaint reports were reviewed and the most likely root cause for this event may have been the large blue vent cap for the shunt sensor was not fully tightened either during setup of the circuit, or after the gas calibration.When the large blue vent cap was loosened, it may not have been re-tightened fully prior to use in the line, causing a 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
• MDR Report Key: 7583590
• MDR Text Key: 110578728
• Report Number: 1124841-2018-00116
• Device Sequence Number: 1
• Product Code: DRY
• UDI-Device Identifier: 00699753160767
• UDI-Public: (01)00699753160767
• Combination Product (y/n): N
• PMA/PMN Number: K972962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/16/2018

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 Model Number: CDI510H
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/18/2018
• Initial Date FDA Received: 06/08/2018
• Supplement Dates Manufacturer Received: 07/11/2018
• Supplement Dates FDA Received: 07/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1