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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/24/2023

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 11.Component code: 510-sensor.Health effect ¿ impact code: 2645- no patient involvement.Health effect ¿ clinical code: 4582- no clinical signs, symptoms or conditions.Medical device problem code: 1354- leak/splash.Investigation findings: 3233 - results pending completion of investigation.Investigation conclusions: 11 - conclusion not yet available.

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during set up, there was a leakage from the shunt sensor before calibration.No patient involvement.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 august 14, 2023.  upon further investigation of the reported event, the following information is new and/or changed: d9 (device availability - added date returned to manufacturer).G3 (date received by manufacturer).G6 (indication that this is a follow-up report).H2 (follow-up due to additional information).H3 (device evaluation anticipated by manufacturer - a second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusions code 11.  all available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

Leakage from the shunt sensor.

Event Description

Leakage from the shunt sensor.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added exp date) g3 (date received by manufacturer) g6 (indication that this is a follow-up report) h2 (follow-up due to additional information and device evaluation) h3 (device evaluated by manufacturer) h4 (device manufacture date) h6 (identification of evaluation codes 10, 3331, 213, 67) type of investigation #1: 10 - testing of actual/suspected device type of investigation #2: 3331 - analysis of production records investigation finding: 213 - no device problem found investigation conclusions: 67 - no problem detected the returned sample was visually inspected upon receipt, during which it was noted that the sparger assembly and white luer cap were not present.A white luer cap was added to the sample.The returned sample was then leak tested, as received by connecting with a calibrated manometer, submerged into a water bath, and pressurized up to 1030 mmhg and a leak was noted immediately.The large bore adapter blue cap was then loosened and re-tightened by hand.It was then leak tested a second time with no leaks were noted.The sample was also connected to a bpm head and leak tested again; no leaks were noted.The root cause for this event was determined to be the large blue vent cap for 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 had not been re-tightened fully, 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 (Section G): SAME
• Manufacturer Contact: douglas patton ; 125 blue ball road; elkton, MD 21921 ; 7346634145
• MDR Report Key: 17545495
• MDR Text Key: 321276535
• Report Number: 1124841-2023-00203
• Device Sequence Number: 1
• Product Code: DRY
• UDI-Device Identifier: 00699753160767
• UDI-Public: (01)00699753160767
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K972962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2023

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: 04/30/2024
• Device Model Number: CDI510H
• Device Catalogue Number: N/A
• Device Lot Number: 3F08F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/26/2023
• Initial Date FDA Received: 08/14/2023
• Supplement Dates Manufacturer Received: 08/11/2023; 09/19/2023
• Supplement Dates FDA Received: 09/01/2023; 10/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2023
• 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