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 Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The end user compared the values to the point of care (poc) read out to verify inaccuracy.
Event or Problem Description
It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the hematocrit saturation module (h/sat) was displaying inaccurate values.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.
Additional Manufacturer Narrative
Updated blocks: d10 and h3.H3: 81 evaluation is in progress, but not yet concluded.
Additional Manufacturer Narrative
The reported complaint was not verifiable.Multiple diligence attempts were unsuccessful for part return, so an evaluation could not be completed.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
Event or Problem Description
Additional information was received that the inaccurate values were observed prior to an in-vivo calibration.
Additional Manufacturer Narrative
During laboratory analysis, the product surveillance technician (pst) observed the hematocrit saturation (h/sat) values could be adjusted using the in-vivo recalibration function.There were no abnormalities noted throughout the evaluation.
Event or Problem Description
Per clinical review: the unit was set up without issue for a procedure on (b)(6) 2020.The unit passed its color chip.During cardiopulmonary bypass (cpb) procedure, the hematocrit saturation module (h/sat) values were inaccurate post in-vivo, therefore the clinician opted to exchange the unit.There was no delay in the continuation of the surgical procedure.There was no harm or blood loss due to the issue.
Additional Manufacturer Narrative
The reported complaint could not be confirmed.The service repair technician (srt) was not able to duplicate the reported issue.The hematocrit saturation (h/sat) passed service mode testing and no errors or irregular values occurred during testing.The monitor booted up intermittently with an h/sat color chip error.The h/sat probe was the most likely cause and was replaced as a precaution.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
• 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
• MDR Report Key: 9939851
• Report Number: 1828100-2020-00159
• Device Sequence Number: 16911734
• Product Code: DRY
• UDI-Device Identifier: 00886799001646
• UDI-Public: (01)00886799001646(11)170919
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K133658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/07/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/26/2020
• Supplement Date Received by Manufacturer: 05/27/2020; 06/10/2020; 07/02/2020; 04/27/2021
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 06/09/2020; 06/30/2020; 07/22/2020; 05/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1