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 500AVHCT

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

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

Event Date 10/19/2022

Event Type  malfunction  

Manufacturer Narrative

81 evaluation is in progress, but not yet concluded.Per the perfusionist, a sample was sent to the lab and the bpm was recalibrated, but the value remained to be 100 even when a different value was entered.There were no disposables changed out, no error codes on the unit and the other values (hematocrit and hemoglobin) were accurate.

Event Description

It was reported that during use of the device for cardiopulmonary bypass (cpb), the blood parameter monitor (bpm) venous saturation always read 100%.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: the user reported using a bpm during cpb, at which time the venous saturation noted to always be reading 100%.The unit was changed out without any delay in the procedure.The surgery was completed successfully.There was no blood loss, or adverse event reported.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) powered the blood parameter monitor (bpm) on without any failures.The pst did not observe any issues during evaluation.On screen hematocrit (hsat) values were successfully adjusted throughout the system's display range using the store and recall function on the monitor.It was determined that the bpm met specification.

Manufacturer Narrative

The reported complaint could not be confirmed.The service repair technician (srt) was unable to duplicate the reported issue.The monitor powered on and passed the self-test.Arterial and venous blood parameter monitor (bpm) probes and the hematocrit saturation (h/sat) probe all passed service mode tests and intensity tests.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.

• 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: 15780166
• MDR Text Key: 307105007
• Report Number: 1828100-2022-00387
• Device Sequence Number: 1
• Product Code: DRY
• 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
• Report Date: 12/22/2022

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: 500AVHCT
• Device Catalogue Number: 500AVHCT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/19/2022
• Initial Date FDA Received: 11/11/2022
• Supplement Dates Manufacturer Received: 11/14/2022; 12/15/2022
• Supplement Dates FDA Received: 12/05/2022; 12/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2008
• 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