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

Model Number CDI510H

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 12/07/2016

Event Type  malfunction  

Manufacturer Narrative

Terumo has not received the actual device.Evaluation in progress.Terumo plans on submitting a follow-up report when the investigation is complete and more information becomes available.(b)(4).

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, liquid leakage from the vent lure adapter was found.The shunt sensor was replaced by a new one.No patient involvement.Product was changed out.Surgery 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 19, 2016.The actual device was returned for evaluation.A review of the device history record revealed no manufacturing anomalies.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.The sample was found to not hold any pressure, and was leaking from the top of the white cap on the large blue luer adapter.Upon further visual inspection, it was discovered that the white cap that was returned with the sample was not a terumo white cap that is used to manufacture the shunt sensors.There was a hole in the end of this incorrect white cap, which was allowing the shunt sensor to leak.A terumo white cap was then connected to the sample and it was gradually pressurized to roughly 1000mmhg for 30 seconds, being sure that all caps and connections were tightened and closed.No leaks were observed during the test.The sample was then coupled with a bpm head and the test was repeated.No leaks were observed during this test.It is likely that during setup or use, a different, vented white luer cap was connected to the shunt sensor by mistake, rather than reconnecting the terumo cap to the unit.This caused the device to leak during use.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 CORP.; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6186474
• MDR Text Key: 62751609
• Report Number: 1124841-2016-00431
• 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: 01/20/2017

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: 07/31/2017
• Device Model Number: CDI510H
• Device Catalogue Number: N/A
• Device Lot Number: UK15E
• Other Device ID Number: (01)00699753160767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/11/2016
• Initial Date FDA Received: 12/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2016
• 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