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 500AVHCT

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

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

Event Date 06/21/2021

Event Type  malfunction  

Manufacturer Narrative

Per the manufacturer¿s subsidiary, after replacing the bpm, the user became concerned about the data reliability.When the bpm was checked, it was found that the arterial and venous temperatures were 15 degrees celsius different from each other.It was also found that the arterial temperature measurement was unstable.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the temperature measurement that displayed on the blood parameter unit (bpm) was six degrees celsius higher than the temperature displayed on the heart lung machine (hlm).As mitigation, an external device was used to track data.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

Updated block: h6.The reported complaint was confirmed.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) observed the temperature readings from the arterial bpm probe to be erratic and unreliable.He powered up the monitor and observed no logged arterial bpm error codes in the erasable electronically programmable read only memory (eeprom).There was no visual damage to the arterial bpm probe.The monitor was in operate mode for approximately one hour and there was an immediate 3.5 degree to 6.0 degree difference in the arterial and venous bpm temperature readings.Both the probes were placed in the lab refrigerator with a setpoint of 15 degrees celsius.The probes were kept inside the refrigerator for approximately two hours.The arterial bpm read 16.6 degrees and the venous bpm read 16.7 degrees.Both probes were removed from the refrigerator and allowed to come to room temperature.Within approximately five minutes the arterial bpm read 5.9 degrees and the venous bpm read 19.0 degrees.The pst installed a lab use only (luo) bpm probe in the monitor and the test was repeated.During both phases of the test, the luo bpm temperature readings of both probes remained within one tenth of one percent of each other.It was determined that the customer's arterial bpm probe was erratic and unreliable.

Event Description

Per clinical review: the manufacturer clinical specialist spoke with the manufacturer's subsidiary regarding the incident the team had with the blood parameter monitor (bpm) during a cardiopulmonary bypass (cpb) procedure on (b)(6) 2021.The team set up and calibrated the bpm without issue for a procedure.Once on bypass the clinical team noticed that the bpm displayed that the temperature was six degrees celsius higher than the one displayed on the heart lung machine (hlm).The manufacturer clinical specialist was able to reiterate the information in the instruction for use (ifu) that the temperature on the display is for algorithm use and not for patient use.No other clinical parameters were out of range/accuracy.There was no delay in the continuation of the surgical procedure.There was no harm or blood loss.

• 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: 12161146
• MDR Text Key: 261468133
• Report Number: 1828100-2021-00240
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/24/2021

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
• Device Operator: Health Professional
• Device Model Number: 500AVHCT
• Device Catalogue Number: 500AVHCT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/23/2021
• Initial Date FDA Received: 07/13/2021
• Supplement Dates Manufacturer Received: 08/02/2021; 09/02/2021
• Supplement Dates FDA Received: 08/23/2021; 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1