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

Model Number CDI510H

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/14/2023

Event Type  Injury  

Manufacturer Narrative

Terumo has received the device for evaluation; however, 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.H6: component code: 510 - sensor.Health effect - impact code: 1988 - overdose.Health effect - clinical code: 4582 - no clinical signs, symptoms or conditions.Medical device problem code: 1535 - incorrect, inadequate or imprecise result or readings.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 there was a significant drift in continuous blood gas measurements made by the arterial cell.It is unknown when the event occurred.Terumo continues to attempt to gain more information regarding this event from the user facility.As per the subsidiary, a newborn was surgically treated for type i open septal pulmonary atresia.They discovered the event at the start of the extracorporeal circulation period.During intervention, the nurse perfusionist observed a significant drift in continuous blood gas measurements made by the arterial cell.The professional specified that given the values observed, he should have administered 8.4% sodium bicarbonate solution on numerous occasions, and with cumulative doses that were far too high for the age and build of the patient.An administration of unnecessary 8.4% bicarbonate was compensated for the newborn.The professional took a sample to measure blood gases and noted the drift.They took blood gases closely and repeatedly to mitigate the issue.*no known health consequences or impact to patient.*product was not changed out.*procedure 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 october 13, 2023.Upon further investigation of the reported event, the following information is new and/or changed: b5 (describe event or problem - added new information).D4 (additional device information - added expiration 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, 11, 3331, 213, 67).Type of investigation #1: 10 - testing of actual/suspected device type of investigation #2: 11 - testing of device from same lot/batch retained by manufacturer.Type of investigation #3: 3331 - analysis of production records.Investigation findings: 213 - no device problem found.Investigation conclusions: 67 - no problem detected.The returned sample was visually inspected upon receipt, using the cdi 500 and cdi 540, gas calibration on the returned sample was attempted and was found to be successfully gas calibrated with no issues.A retention sample from the same product code and lot number was found to be successfully gas calibrated with no issues.The complaint and retention sample were then circulated with buffer solution and found to produce consistent values on the cdi500 monitor.All values were normal results and displayed for the extent of the testing.The samples were found to perform as expected during the investigation.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

New information received that the event occurred during cardiopulmonary bypass.

• 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: 17932648
• MDR Text Key: 325632014
• Report Number: 1124841-2023-00242
• Device Sequence Number: 1
• Product Code: DRY
• UDI-Device Identifier: 00699753160767
• UDI-Public: (01)00699753160767
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• Is this an Adverse Event Report?: Yes
• 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: 3F22G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2023
• 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
• Patient Outcome(s): Required Intervention