MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CDI BLOOD PARAMETER MONITORING SYSTEM 550; CARDIOPULMONARY BYPASS ON-LINE BLOOD GAS

Model Number 550AHCT

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

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

Event Date 03/04/2021

Event Type  malfunction  

Manufacturer Narrative

Per the manufacturer's subsidiary, later on the same day, the perfusionist could not calibrate the shunt sensor on the same unit.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the blood parameter monitor (bpm) had inaccurate parameters as the delivery of oxygen (do2) was larger than the partial pressure of oxygen (po2).The values were double checked with the blood gas machine.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Event Description

Per clinical review: the manufacturer's clinical specialist spoke with the subsidiary, regarding the issue the team had with the blood parameter monitor (bpm), during a cardiopulmonary bypass (cpb) procedure on (b)(6) 2021.The subsidiary reported, that the delivered oxygen (do2) was reading a larger number than the pressure of oxygen (po2).The manufacturer's clinical specialist asked, the subsidiary if they placed the body surface area (bsa) in the bpm, prior to the calibration.The team stated, the bsa was entered before the calibration.It would be needed to know, if the do2 value was indexed to the patient bsa.Additionally, the manufacturer's clinical specialist asked, the subsidiary if they were streaming the flow from the heart lung machine (hlm) to have continuous information on the flow value being entered into the do2 value.The team stated, that the flow was being calculated from the hlm, but did not state, if it was being brought over from the hlm or if it was manually being placed in the bpm.The manufacturer's clinical specialist asked, if the team had calculated the value to see if what was being displayed was what they were calculating by hand, but no information regarding that was received.This issue did not delay the surgical procedure.There was no harm or blood loss, due to the concern.The bpm was not exchanged out.

Manufacturer Narrative

Updated block: b5.

Manufacturer Narrative

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.

• Brand Name: CDI BLOOD PARAMETER MONITORING SYSTEM 550
• Type of Device: CARDIOPULMONARY BYPASS ON-LINE BLOOD GAS
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 11920525
• MDR Text Key: 260280960
• Report Number: 1828100-2021-00190
• Device Sequence Number: 1
• Product Code: DRY
• UDI-Device Identifier: 00886799001790
• UDI-Public: (01)00886799001790(11)190303
• Combination Product (y/n): N
• PMA/PMN Number: K182110
• 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: 10/25/2021

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 Model Number: 550AHCT
• Device Catalogue Number: 550AHCT
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/10/2021
• Initial Date FDA Received: 06/02/2021
• Supplement Dates Manufacturer Received: 07/26/2021; 10/04/2021
• Supplement Dates FDA Received: 08/16/2021; 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BLOOD GAS ANALYZER