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 Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the user facility's biomedical technician, the issue occurred about two weeks before it was reported.The inaccurate values were for partial pressure of carbon dioxide (pco2).
Event or Problem Description
It was reported that prior to the use of the device for a cardiopulmonary bypass (cpb) procedure, the blood parameter monitor (bpm) values 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.
Additional Manufacturer Narrative
The reported complaint could not be confirmed.During laboratory analysis, the product surveillance technician (pst) observed that the on-screen values could be adjusted to sample values throughout the evaluation.A sample 540 calibration was completed successfully.The monitor operated as intended throughout the evaluation.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
Per clinical review: multiple diligence attempts were unsuccessful in obtaining additional clinical information.The details available are that the values were off from what was expected when the monitor was being used during an extracorporeal membrane oxygenation (ecmo) procedure.
Additional Manufacturer Narrative
H3: 81 - evaluation is in progress, but not yet concluded.

• 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: 10253428
• Report Number: 1828100-2020-00256
• Device Sequence Number: 18961608
• Product Code: DRY
• UDI-Device Identifier: 00886799001646
• UDI-Public: (01)00886799001646(11)990901
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2020

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: 500AVHCT
• Device Catalogue Number: 500AVHCT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 07/16/2020; 08/13/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 08/05/2020; 08/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1828100-08/07/15-002-C
• Patient Sequence Number: 1