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

Model Number	550AVHCT
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	12/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the manufacturer's subsidiary, the display values were very different, especially at rewarming.The potassium (k) value displayed '1' twice.Other bpms used by the facility have no issues with their values.The end-user does calibration regularly.
Event or Problem Description
It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the blood parameter monitor (bpm) displayed inaccurate values.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
Event or Problem Description
Per clinical review: the manufacturer's clinical specialist attempted to gather information on the complaint, the priming solution and the cadence of the procedure, but no additional information was available.The team had an incident with the blood parameter monitor (bpm) during a cardiopulmonary bypass (cpb) procedure on 21-dec-2020.The team set up and calibrated without issue for the case.During the procedure the potassium displayed one millimoles per liter (mmol/l).The team tried to re-invivo the unit and the sensor was still reading the same one mmol/l value.The patient's potassium was in the normal range.The team invivo-ed numerous times without a change.The unit was used for the remainder of the procedure.There was no delay in the continuation of the surgical procedure.There was no harm or blood loss associated with the event.
Additional Manufacturer Narrative
During laboratory analysis, the product surveillance technician (pst) could not duplicate the reported complaint.There were no errors logged in the erasable electronically programmable read only memory (eeprom).The monitor was powered up and put in operate mode, several in vivo adjustments were performed over the course of approximately two hours.All adjustments were accepted and reflected by the monitor display.No volatility was observed at any point.
Additional Manufacturer Narrative
The reported complaint could not be confirmed.The service repair technician (srt) was unable to duplicate the reported issue.The h/sat passed service mode testing.The arterial and venous blood parament monitors (bpm) passed intensity testing.There were no noted errors or malfunctions throughout testing.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 550
• Common Device Name: CARDIOPULMONARY BYPASS ON-LINE BLOOD GAS
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 11148466
• Report Number: 1828100-2021-00013
• Device Sequence Number: 16301415
• Product Code: DRY
• UDI-Device Identifier: 00886799001783
• UDI-Public: (01)00886799001783(11)190822
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K182110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/30/2021

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: 550AVHCT
• Device Catalogue Number: 550AVHCT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/21/2020
• Supplement Date Received by Manufacturer: 01/19/2021; 04/15/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 02/12/2021; 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1