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 03/26/2021

Event Type  malfunction  

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the venous saturation stayed at 100% despite being adjusted to 70%.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Event Description

It was concluded that the reported issue occurred during use of the device for a cardiopulmonary bypass (cpb) procedure.Per clinical review: the manufacturer's clinical specialist spoke with the perfusionist regarding the incident the team had with the blood parameter monitor (bpm) during a cardiopulmonary bypass (cpb) procedure on (b)(6) 2021.The bpm passed the color chip test without issue.The team initiated cpb and the bpm venous saturation was reading 100% before and after the venous in-vivo calibration.The perfusionist did not exchange the unit out and continued the procedure without the correct reading.There was no delay in the continuation of the surgical procedure.There was no harm or blood loss due to the issue.

Manufacturer Narrative

The reported complaint was not confirmed.The service repair technician (srt) could not reproduce the issue.The monitor powered on and passed self-test and the arterial blood parameter monitor (bpm) passed intensity test.The hematocrit saturation (hsat) passed service mode testing.The unit operated to the manufacturer's specifications.The hsat was replaced to address the color chip errors received during laboratory analysis.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) did not observe the reported complaint.He powered up the monitor and the erasable electronically programmable read only memory (eeprom) had 15 recorded color chip failures.The pst powered the monitor up in service mode and the color chip test was performed two times, once as received and the second after cleaning.The first test, the ir1 channel failed product specification limit of +/- 12.5% with a value of 18.1%.The red channel exceeded the service alert limit of +/- 10% with a value of -11.6%, the color chip and the optical surface were cleaned, and the test was performed a second time.The results were improved with a ir1 value of 11.0% which exceeds the service alert limit but not the product specification limit.The red value was -5.7% which was a passing value in all required limits.A lab use only (luo) hematocrit saturation module (h/sat) probe was installed and the monitor powered up normally and passed all monitor start-up checks as expected.After the customer h/sat probe was reinstalled, the monitor was powered up in operate mode.A luo 3/8 inch cuvette was attached and the monitor was left in operate mode with an 84% oxygen saturation (so2) setting for a minimum of eight hours (overnight).After approximately 13 hours, the so2 level had only decreased to 83%.Several in-vivo adjustments were made over approximately the next two hours.All in-vivo adjustments were accepted and reflected properly on the monitor display.

• 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: 11697597
• MDR Text Key: 247571265
• Report Number: 1828100-2021-00144
• Device Sequence Number: 1
• Product Code: DRY
• UDI-Device Identifier: 00886799001622
• UDI-Public: (01)00886799001622(11)120724
• Combination Product (y/n): N
• PMA/PMN Number: K133658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• 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: 08/03/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1