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 07/13/2021

Event Type  malfunction  

Manufacturer Narrative

Per the manufacturer's sales associate, the perfusionist reported that the inaccurate pco2 and po2 values were displayed after in-vivo calibration.A second calibration did not correct the trending accuracy.The actual po2 was 47 and the bpm was trending it at 37.

Event Description

It was reported that during use of the device for cardiopulmonary bypass (cpb), the blood parameter monitor (bpm) displayed different partial pressure of oxygen (po2) and partial pressure of carbon dioxide (pco2) values than the blood gas analyzer.As a mitigation, more blood gases were done.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 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 bpm without issue.After the first in-vivo calibration on cpb, the perfusionist noticed that the partial pressure of carbon dioxide (pco2) and partial pressure of oxygen (po2) values were very off from the blood gases, example of pco2 of 37 millimeters of mercury (mmhg) on the bpm and the blood gas analyzer was reading 47 mmhg.The team did more blood gas values during the procedure, and exchanged the bpm after the procedure.There was no delay in the continuation of the surgical procedure.There was no harm or blood loss.

Manufacturer Narrative

Updated block: h6.The reported complaint was not confirmed.The service repair technician (srt) could not duplicate the issue.The blood parameter monitor (bpm) powered on and passed the self-test.The arterial bpm passed intensity testing, the hematocrit saturation (hsat) passed service mode testing, and the erasable electronically programmable read only memory (eeprom) contained 0 critical errors.The monitor passed all testing.The unit operated to the manufacturer's specifications.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

During laboratory analysis, the product surveillance technician (pst) put the blood parameter monitor (bpm) into operate mode with a shunt sensor attached to the bpm and a cuvette attached to the hematocrit saturation (hsat).The system was left alone for approximately five minutes, then the store/recall function was used to adjust on-screen values with no issues observed.A sample calibration was successful.The operate mode observation was repeated and no issues observed adjusting on-screen values.The monitor was left in operate mode for two hours and the values did not change unexpectedly during that time.

• 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: 12274414
• MDR Text Key: 264970882
• Report Number: 1828100-2021-00264
• Device Sequence Number: 1
• Product Code: DRY
• UDI-Device Identifier: 00886799001622
• UDI-Public: (01)00886799001622(11)171101
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/09/2021

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: 500AHCT
• Device Catalogue Number: 500AHCT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/13/2021
• Initial Date FDA Received: 08/04/2021
• Supplement Dates Manufacturer Received: 08/15/2021; 09/23/2021; 10/22/2021
• Supplement Dates FDA Received: 09/08/2021; 10/18/2021; 11/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2017
• 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; BLOOD GAS ANALYZER