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
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the perfusionist, they were about 60 minutes into a cpb procedure when some of the measured values on the bpm went missing and displayed an error.The perfusionist turned the unit off, replaced the sensors, then restarted the unit.It was then that the arterial numbers were larger than expected, and the venous numbers were different than where they were previously.The data collection system never resumed pulling the bpm data and the data had to be manually entered.
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), the blood parameter monitor (bpm) was not sending data to the data collection system.Upon replacing the sensors and rebooting the system, the arterial measured parameters were larger than expected, and the venous measured parameters were also different than where they were previously.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
Additional Manufacturer Narrative
The reported complaint was not verifiable since the product was not returned for evaluation or testing.The device was not returned as the user facility continued to use it with no further issues.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
Updated block: b5.
Event or Problem Description
Per clinical review: on (b)(6) 2021, the team experienced a problem with the blood parameter monitor (bpm) during a cardiopulmonary bypass (cpb) procedure.They reported that the unit stopped sending data during the case.The end user proceeded to turn off the unit, replaced the sensors, and restarted the unit and it functioned as normal.The procedure was completed successfully with no delay, no blood loss, and no change-out.

• Brand Name: CDI BLOOD PARAMETER MONITORING SYSTEM 500
• Common Device Name: 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: 12583643
• Report Number: 1828100-2021-00354
• Device Sequence Number: 14376380
• Product Code: DRY
• UDI-Device Identifier: 00886799001646
• UDI-Public: (01)00886799001646(11)170314
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K133658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/10/2021

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
• Operator of Device: Health Professional
• Device Model Number: 500AVHCT
• Device Catalogue Number: 500AVHCT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2021
• Supplement Date Received by Manufacturer: 10/13/2021; 11/18/2021
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 11/04/2021; 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown