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
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation is in progress, but not yet concluded.
Event or Problem Description
It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the hemoglobin (hgb) and hematocrit (hct) readings were inaccurate.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: during cpb on (b)(6) 2020, the blood parameter monitor (bpm) was powered up and passed color chip test without an issue.During cpb, approximately four hours into the bypass run (post in-vivo calibration) the bpm started to give inaccurate numbers on the hct and hgb, and the venous saturation value did not appear.There was nothing wrong with the patient, or the physical probe or cuvette, for it had worked perfectly up until this issue occurred.The team cycled power, and the same result of the hgb and hct numbers going up and down and the venous saturation levels not reading.There were no issues with the arterial gases.The team opted to exchange the unit during the procedure.
Additional Manufacturer Narrative
During laboratory analysis, the product surveillance technician observed no inaccuracies.In-vivo adjustments could be performed to adjust the hematocrit saturation (h/sat) values within the on-screen range for each h/sat value.The unit operated to the manufacturer's specifications.
Additional Manufacturer Narrative
The reported complaint could not be confirmed.The service repair technician was unable to duplicate the reported issue.He replaced the hematocrit saturation (h/sat) spring clip 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: 9770028
• Report Number: 1828100-2020-00094
• Device Sequence Number: 2574612
• Product Code: DRY
• UDI-Device Identifier: 00886799001622
• UDI-Public: (01)00886799001622(11)130528
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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
• Report Date (Section B): 05/18/2020

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: 500AHCT
• Device Catalogue Number: 500AHCT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 03/27/2020; 05/08/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 04/21/2020; 05/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1