MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CDI BLOOD PARAMETER MONITORING SYSTEM 550; MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 550

Model Number 550AHCT

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

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

Event Date 05/10/2021

Event Type  malfunction  

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the measured hemoglobin (hgb) value would drop low for no reason.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.

Manufacturer Narrative

Updated blocks: h3 and h6 during laboratory analysis, the product surveillance technician (pst) observed the performance of the hematocrit/saturation (h/sat) remained steady throughout evaluation.The complaint indicated volatility in h/sat output.The spring clip was loose and was reattached and then the monitor was put into operate mode.Sample h/sat values were set using an in-vivo adjustment.The system was left in operate mode for four hours and the values were checked again.Values did not significantly change during this time.Sample h/sat on-screen values remained steady for several hours.

Event Description

Per clinical review: according to the information available, the team at the user facility had an incident with the blood parameter monitor (bpm) on (b)(6) 2021 during a cardiopulmonary bypass (cpb) procedure.Additionally, the team had an issue with the bpm not passing its color chip during set up.The reading of the hemoglobin was inaccurate, for it was low compared to the blood gas analyzer.It is not known if the occurrence was before or after a first in-vivo calibration.There was no delay in the continuation of the surgical procedure.There was no harm or blood loss.

Manufacturer Narrative

The reported complaint could not be confirmed.The service repair technician (srt) observed the monitor to pass power on self tests with no errors.The hematocrit saturation (h/sat) probe passed color chip and cuvette testing several times within specification.The reported complaint could not be confirmed.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 550
• Type of Device: MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 550
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 11920513
• MDR Text Key: 260284172
• Report Number: 1828100-2021-00191
• Device Sequence Number: 1
• Product Code: DRY
• UDI-Device Identifier: 00886799001790
• UDI-Public: (01)00886799001790(11)190208
• Combination Product (y/n): N
• PMA/PMN Number: K182110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/09/2021

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: 550AHCT
• Device Catalogue Number: 550AHCT
• Device Lot Number: 1124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/10/2021
• Initial Date FDA Received: 06/02/2021
• Supplement Dates Manufacturer Received: 06/03/2021; 06/25/2021; 08/06/2021
• Supplement Dates FDA Received: 06/25/2021; 07/16/2021; 08/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BLOOD GAS ANALYZER