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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Per the manufacturer's sales associate, the issue had been occurring for a while.The user did not calibrate the bpm pre bypass, only on bypass using the blood analyzer.

Event Description

It was reported that during use of the device for cardiopulmonary bypass (cpb), the values on the blood parameter monitor (bpm) were inaccurate.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Event Description

Per clinical review: on 05apr2022, the manufacturer was informed of a problem with the user facility's blood parameter monitor (bpm).The complaint was for inaccuracy, described as 'bpm results vary from last'.Per the manufacturer's sale associate, the issue had been going on since last year and had been occurring for a while on the unit.It was an old unit, and the user did not calibrate with gas a and b pre bypass, they calibrate on bypass with the istat.This issue occurred while on cardiopulmonary bypass (cpb).The unit was not changed out.There was no delay, no blood loss, and the procedures were completed successfully.

Manufacturer Narrative

Updated blocks: b5, d9, h3 and h6 during laboratory analysis, the product surveillance technician (pst) observed the monitor to boot up without any failures.Standard reference sensor (srs) and color chip testing was performed successfully.The pst used the bpm in factory default mode for calibration values.In operate mode, the monitor's on-screen values were adjusted to sample values successfully.The pst did not observe any sudden changes during sample operation.It was determined that the monitor functioned as intended.

Manufacturer Narrative

The reported complaint could not be confirmed.The service repair technician (srt) could not duplicate the reported complaint.The monitor powered on and passed self testing.The arterial blood parameter monitor (bpm) probe passed intensity testing and the hematocrit saturation (h/sat) probe passed service mode testing.The monitor passed all applicable 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 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
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 14251468
• MDR Text Key: 290398557
• Report Number: 1828100-2022-00175
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/10/2022

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: 500AHCT
• Device Catalogue Number: 500AHCT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/05/2022
• Initial Date FDA Received: 04/29/2022
• Supplement Dates Manufacturer Received: 06/08/2022; 08/03/2022
• Supplement Dates FDA Received: 06/29/2022; 08/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: I-STAT BLOOD ANALYZER.