MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CDI BLOOD PARAMETER MONITORING SYSTEM 500; MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500

Model Number 500AHCT

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

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

Event Date 10/12/2023

Event Type  malfunction  

Manufacturer Narrative

Per the manufacturer's subsidiary, the potential hydrogen (ph), partial pressure of oxygen (po2), and the partial pressure of carbon dioxide (pco2) values were not shown at first.The bpm was recalibrated, but the issue remained.The shunt sensor was replaced and although the values did display, they were considerably deviated from the bga values.

Event Description

It was reported that during use of the device for cardiopulmonary bypass (cpb), the blood parameter monitor (bpm) values were deviating considerably from the blood gas analyzer (bga) values and the probe was hotter to the touch than usual.As mitigation, the shunt sensor was replaced but the issue remained.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Event Description

Per clinical review: on (b)(6) 2023 the team experienced a problem with their blood parameter monitor (bpm) while on cardiopulmonary bypass (cpb), whereby the values were considerably deviated from the laboratory values, and the probe was noted to be hotter than usual.The sequence from the description was that at first, there was no potential hydrogen (ph), partial pressure of oxygen (po2), or partial pressure of carbon dioxide (pco2) data.The team performed a recalibration and the issue remained.The team changed the shunt sensor, and the issue was resolved, but it was noted that it was inaccurate, and that the bpm probe was hotter than usual.The bpm was not changed out.There was no blood loss, no delay, and the procedure was completed successfully.

Manufacturer Narrative

Updated block: b5.

Manufacturer Narrative

The reported complaint was non-verifiable as no product was returned.Multiple diligence attempts for part return were unsuccessful therefore further evaluation and root cause analysis could not be performed.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• Brand Name: CDI BLOOD PARAMETER MONITORING SYSTEM 500
• Type of Device: MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 18074899
• MDR Text Key: 327423871
• Report Number: 1828100-2023-00339
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123039
• 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: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 500AHCT
• Device Catalogue Number: 500AHCT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: BLOOD GAS ANALYZER