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 11/09/2021

Event Type  malfunction  

Manufacturer Narrative

Per the user facility's biomedical technician, the reported issue would not correct despite multiple calibrations.Per the perfusionist, the issue has been ongoing and have not been able to figure out a cause from a clinical aspect.They experience the partial pressure of carbon dioxide (pco2) to rise when rewarming.

Event Description

It was reported that during use of the device for cardiopulmonary bypass (cpb), the arterial sensor on the blood parameter machine (bpm) values were trending in the opposite direction than expected.As a result, an alternative device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

Updated blocks: d9 and h3, h3, 81 evaluation is in progress but not yet concluded.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) booted up the monitor without any failures.The erasable electronically programmable read only memory (eeprom) indicated no error codes and no blood parameter monitor (bpm) failures.With a standard reference sensor test (srs) clipped to the bpm, the on-screen values were adjusted to sample values.The system ran for two hours.The values on the screen remained as adjusted except for the potassium (k+) value, which increased steadily as expected.The software anticipates and compensates for the reactions of the k+ chemistry to the light emitting diode (led) light over time.To ensure accuracy, periodic adjustments were necessary using the store/recall function.All values on the screen were successfully adjusted throughout their display ranges.This was checked when the monitor was first put into operate mode, and after the monitor had been operating overnight.It was determined that the bpm met specification.

Event Description

Per clinical review: on (b)(6) 2021, the team experienced a problem with the blood parameter monitor (bpm) whereby the arterial line sensor kept trending in the opposite direction and would not correct despite multiple calibrations.This occurred during cardiopulmonary bypass (cpb) and the unit was changed out, with no subsequent blood loss, no delay and no adverse event, and the procedure was completed successfully.

Manufacturer Narrative

Updated block: h6 the reported complaint was confirmed.The service repair technician (srt) could not duplicate the reported complaint upon power up.The hematocrit saturation (h/sat) probe passed the color chip/cuvettes testing in service mode.The arterial blood parameter monitor (bpm) probe failed intensity testing, but the electronically erasable programmable memory (eeprom) did not list any critical error codes.The arterial bpm probe was replaced as a precautionary measure for possible intermittent issues.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: 12925278
• MDR Text Key: 281683257
• Report Number: 1828100-2021-00465
• 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,Followup
• Report Date: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• 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: 12/17/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2009
• 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