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	10/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation is in progress, but not yet concluded.This complaint is related to (b)(4)/ medwatch #1828100-2019-00565.
Event or Problem Description
It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the monitor had an erroneous temperature reading.Other available temperature readings were used as an alternative.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: the team set up and calibrated the blood parameter monitor (bpm) and shunt sensor without issue for procedures on (b)(6) 2019, and (b)(6).Shortly after commencing cpb the shunt sensor temperature went from 36.5 to 45 degrees celsius (c).The team confirmed that their patient's temperature was appropriate at around 36.The team reseated the shunt sensor in the bpm head and again the temperature was reading 45 degrees c.It was confirmed that the team did not notice or detect any other parameter inaccuracies, but the interval in which they take arterial blood gas (abg) was about every 30 to 45 minutes.The team stated that it was the same monitor and the same lot number for the shunt sensor in all three instances.The team did switch the unit out after the procedure on (b)(6).None of instances was there a delay in the surgical procedure.There was no blood loss or harm associated with the events.
Additional Manufacturer Narrative
During laboratory analysis, the product surveillance technician (pst) observed that the arterial blood parameter monitor (bpm) was causing higher than expected temperatures.The on-screen temperature was more than 10 degrees higher than a multimeter and a comparable lab use only (luo) bpm.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: 9259673
• Report Number: 1828100-2019-00572
• Device Sequence Number: 11746028
• Product Code: DRY
• UDI-Device Identifier: 00886799001622
• UDI-Public: (01)00886799001622(11)120917
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 12/06/2019

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: 10/18/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 12/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1