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 Date 02/12/2022

Event Type  malfunction  

Event Description

It was reported that during use of the device for cardiopulmonary bypass (cpb), the blood parameter monitor (bpm) temperature reading dropped, reading 29-33 degrees celsius.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

Evaluation is in progress but not yet concluded.Per the user facility's biomedical engineer, on (b)(6) 2022, the temperature reading on the unit dropped, reading 29-30 degrees celsius.The unit was flushed and there was no change.The unit was troubleshot and the arterial cuvette was changed out.Recalibration of the unit corrected all numbers with the exception of the blood temperature reading.On (b)(6) 2022, the temperature reading corrected itself and functioned correctly for the next couple of days.On (b)(6) 2022 the temperature reading dropped again with readings between 29-33 degrees celsius.The unit was flushed again with no improvement.Patient was unaffected by the issue.Both the water heater and the patient temperatures were stable at about 38 degrees celsius and 36-37 degrees celsius respectively.This complaint is related to (b)(4) / mfr#1828100-2022-00094.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) booted up the monitor without failure and the erasable electronically programmable read only memory (eeprom) indicated zero error codes.The temperature was monitored using a multimeter and a thermocouple throughout the monitor's operating range.No significant discrepancies or sudden changes were observed.It was determined that the bpm met specification.During testing at the service center, the service repair technician also could not duplicate the reported complaint.The unit operated to the manufacturer's specifications.

Event Description

Per clinical review: on (b)(6) 2022, the team experienced a problem with blood parameter monitor (bpm) while on cardiopulmonary bypass (cpb), whereby the temperature began reading inaccurately.The unit was not changed out.There was no blood loss, no delay, and the procedure was completed successfully.

Manufacturer Narrative

Updated block: h6 the reported complaint could not be confirmed.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: 13663676
• MDR Text Key: 286671460
• Report Number: 1828100-2022-00095
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/20/2022

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
• Date Returned to Manufacturer: 02/18/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/16/2022
• Initial Date FDA Received: 03/03/2022
• Supplement Dates Manufacturer Received: 03/08/2022; 04/06/2022
• Supplement Dates FDA Received: 03/29/2022; 04/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2006
• 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