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 06/30/2021

Event Type  malfunction  

Manufacturer Narrative

Per the manufacturer's subsidiary, the bpm showed the hco3 to be 42-43 for about seven minutes, while a blood gas analyzer showed 22.0.In addition, the bpm showed the be to be 14-15 for about seven minutes, while the blood gas analyzer showed the actual base excess (abe) to be -3.2 and the standard base excess (sbe) to be -3.5.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the blood parameter monitor (bpm) displayed abnormal bicarbonate (hco3) and base excess (be) values.As mitigation, a blood gas analyzer was used to check the values, which were stable.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

Updated blocks: h3 and h6.The reported complaint was not verifiable, since the product was not returned for evaluation or testing.Multiple diligence attempts for part return were unsuccessful.If additional information becomes available on this complaint, that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Manufacturer Narrative

Updated block: b5.

Event Description

Per clinical review: the team at the user facility, had an incident with the blood parameter monitor (bpm), during a cardiopulmonary bypass (cpb) procedure on (b)(6) 2021.The team set up and calibrated the unit without issue for the procedure.Once on bypass, the bpm showed the bicarbonate (hco3) to be 42 to 43 for about seven minutes, while an arterial blood gas (abg) machine showed 22.0.In addition, the bpm showed, base excess (be) to be 14 to 15 for about seven minutes, while the abg machine showed, arterial be to be -3.2 and -3.5.Since the hco3 and be values suddenly changed, during cpb, the abg was used to check the measurement.Which was stable.The team did not exchange the shunt sensor, nor the bpm hardware.And used abg values for the patient.There was no delay in the continuation of the surgical procedure.There was no harm or blood loss, due to this issue.

• 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
• MDR Report Key: 12203725
• MDR Text Key: 263552697
• Report Number: 1828100-2021-00250
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• PMA/PMN Number: K123039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BLOOD GAS ANALYZER