MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CDI BLOOD PARAMETER MONITORING SYSTEM 550; CARDIOPULMONARY BYPASS ON-LINE BLOOD GAS

Model Number 550AHCT

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2019

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the blood parameter monitor (bpm) was giving inaccurate hemoglobin and hematocrit values.As a result, manual gas values were taken.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.During set-up for a cpb procedure on (b)(6) 2019, the bpm passed its color chip test without issue.The first hemoglobin and hematocrit values were higher than expected, and were not tracking well, until the first in-vivo calibration occurred.The perfusionist stated that once the in-vivo calibration occurred, the values for both the hemoglobin and hematocrit were more in line with the lab values from the blood gas analyzer.The need for an in-vivo recalibration was reiterated, and that the device has published accuracy values that are not in line with expected values until after the first in-vivo calibration.The unit was not exchanged out.There was no blood loss or harm related to the event.There was no delay in the continuation of the surgical procedure.

Manufacturer Narrative

The reported complaint was confirmed.Per the user facility, an in-vivo calibration had not been done.The user has been advised that the monitor does not have accuracy until an in-vivo calibration is completed.The unit is operating as intended and will not be returned for evaluation.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 550
• Type of Device: CARDIOPULMONARY BYPASS ON-LINE BLOOD GAS
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 9488612
• MDR Text Key: 199261195
• Report Number: 1828100-2019-00670
• Device Sequence Number: 1
• Product Code: DRY
• UDI-Device Identifier: 00886799001790
• UDI-Public: (01)00886799001790(11)190208
• Combination Product (y/n): N
• PMA/PMN Number: K182110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 01/29/2020

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
• Device Operator: Health Professional
• Device Model Number: 550AHCT
• Device Catalogue Number: 550AHCT
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 01/23/2020
• Supplement Dates FDA Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BLOOD GAS ANALYZER