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

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation is in progress, but not yet concluded.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, there was a temperature discrepancy.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: the perfusionist set up and calibrated his blood parameter monitor (bpm) shunt sensors with both gas a and gas b, along with placing the potassium (k+) code in the monitor prior to initiation of bypass on (b)(6) 2018.Ten minutes into the cpb procedure, he noticed that his sensor temperature was reading 40.5 celsius (c) and the patients actual temperature was listed as 37.0 c.This temperature difference was before his first in-vivo calibration.He stored his values, and then placed his in-vivo blood gas analyzer values in the bpm and just as the machine was reverting back to operate mode, the k+ parameter read 8 meq (he had placed around 4.0 in the machine), and the machine then gave him a f101 error message.This error message is an arterial bpm hard failure.He turned the bpm off and back on, but was only able to choose a configuration without the arterial bpm.He proceeded with the unit in the hemoglobin, hematocrit saturation module (h/sat) configuration without issue.After this second complaint, the manufacturer's clinical specialist advised him that he should not use the bpm for arterial blood gas parameters, for the unit would continue giving the error message.It was reiterated that he could use it for the hsat parameters in the interim period.The incident did not delay the continuation of the surgical procedure.They supplemented the values with blood gas values from a blood gas analyzer.There was no blood loss or harm associated with the event.

Manufacturer Narrative

The reported complaint was not verifiable.During laboratory analysis, the product surveillance technician (pst) observed the monitor to operate for 23 straight hours (in operate mode) as intended.Next, a water bath temperature test was set-up to test for the temperature inaccuracy.The monitor passed initial startup self-diagnostics with no errors.The monitor then produced a f101 error and had to be restarted (error removes the blood parameter monitor (bpm) from the configuration).When restarting, the monitor also produced an f0a1 error, bpm is taken out of configuration.Water bath temperature testing for inaccuracy cannot be performed since the bpm is disabled due to the errors.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.This complaint is related to (b)(4) / medwatch #1828100-2018-00157.

• Brand Name: CDI BLOOD PARAMETER MONITORING SYSTEM 500
• Type of Device: 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: 7381150
• MDR Text Key: 104154352
• Report Number: 1828100-2018-00163
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• PMA/PMN Number: K133658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 500AHCT
• Device Catalogue Number: 500AHCT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BLOOD GAS ANALYZER