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 07/19/2022

Event Type  malfunction  

Event Description

It was reported that during use of the device for cardiopulmonary bypass (cpb), the blood parameter monitor (bpm) had a malfunction.As mitigation, blood gas analysis was used to monitor the levels of the patient.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

Per the manufacturer's subsidiary, the probes did not function as expected during use.After calibrating against a lab blood gas sample, the hematocrit saturation (h/sat) probe value showed no change in hemoglobin (hb) (out by 3 grams).The temperature reading was high when the patient's temperature was 32 degrees.The saturations then read 50-60% when the arterial blood gas (abg) samples showed mixed venous blood was 75-80%.

Manufacturer Narrative

Per the manufacturer's subsidiary, the venous oxygen saturation (svo2) was frequently reading 100% which was incorrect and higher than the independent analyzer reading.The value jumped around considerably, varying between 80-100% within the span of one minute despite no change in the true svo2.This was verified by checking the formal blood gas many times.During laboratory evaluation, the product surveillance technician (pst) powered up the blood parameter monitor (bpm) and review of the erasable electronically programmable read only memory (eeprom) showed no critical errors.The bpm was put into service mode and the service mode hematocrit saturation (hsat) test was performed four times in multiple scenarios with all results well within the expected parameters.The monitor was powered up in operate mode with a temperature probe attached and the bpm stayed with one degree celsius of the temperature probe throughout the evaluation.It was determined that the bpm met specification.

Event Description

Per clinical review: on (b)(6) 2022, the team experienced a problem with their blood parameter monitor (bpm) while on cardiopulmonary bypass (cpb), whereby the hematocrit saturation (hsat) readings were inaccurate and would not respond to recalibration.The unit was not changed out and there was no blood loss or delay, and the procedure was completed successfully.

Manufacturer Narrative

The service repair technician (srt) could not duplicate the reported complaint.The hematocrit saturation (hsat) probe passed the self-check.The arterial probe failed the self check test and the unit was repaired.The unit operated to the manufacturer's specifications.

Manufacturer Narrative

The reported complaint could not be confirmed.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
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 15199395
• MDR Text Key: 305155942
• Report Number: 1828100-2022-00294
• Device Sequence Number: 1
• Product Code: DRY
• UDI-Device Identifier: 00886799001790
• UDI-Public: (01)00886799001790(11)220331
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K182110
• 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,Followup
• Report Date: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2022
• 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 ANALYSIS.