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

Model Number CDI510H

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 03/22/2018

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.For this reason, terumo references evaluation conclusion code.(b)(4).Results code: results pending completion of evaluation.Conclusions code: 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 is cracked and the down side was leaking.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 april 11, 2018.(b)(4).A sample was not returned for evaluation; nor were any pictures provided.A retention sample from the affected part number and lot number combination was obtained and visually inspected, no visual damage or any other anomalies noted with the part or the packaging.The retention sample was leak tested, passed the leak test and found to function as intended.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.Without the returned device or any other event related information the investigation to this event is extremely limited and the actual root cause cannot be determined 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: 7423049
• MDR Text Key: 105444366
• Report Number: 1124841-2018-00062
• Device Sequence Number: 1
• Product Code: DRY
• 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: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: CDI510H
• Device Catalogue Number: N/A
• Device Lot Number: WA08L
• Other Device ID Number: (01)00699753160767
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1