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

Model Number CDI510H

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 07/10/2018

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, a small leak of blood was found from the blue cap.There was a minimal blood loss.Product was not 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 july 30, 2018.(b)(4).A sample was not returned for evaluation; nor were any pictures provided.A retention sample from the affected p/n and lot # combination was obtained, visually inspected and leak tested.No anomalies were found.A thorough investigation of this complaint cannot be performed, and a definitive root cause of the reported incident cannot be determined.It is likely that during the 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 during the gas calibration, when the large luer cap was loosened, it had not been retightened 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
• MDR Report Key: 7732678
• MDR Text Key: 115527880
• Report Number: 1124841-2018-00166
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/30/2018

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 Expiration Date: 03/31/2019
• Device Model Number: CDI510H
• Device Catalogue Number: N/A
• Device Lot Number: WE23C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/10/2018
• Initial Date FDA Received: 07/30/2018
• Supplement Dates Manufacturer Received: 08/16/2018
• Supplement Dates FDA Received: 08/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1