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

Model Number 550AHCT

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

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

Event Date 07/12/2021

Event Type  malfunction  

Manufacturer Narrative

Per the manufacturer's sales associate, the end user had been doing in-vivo calibrations and it took several times before the unit values were closer to the blood gas values.

Event Description

It was reported that during use of the device for cardiopulmonary bypass (cpb), the blood parameter monitor (bpm) was displaying a different hematocrit (hct) value than the blood gas analyzer.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

Updated block: b5.

Event Description

Per clinical review: the team had an incident 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, for the procedure on that day.After the first in-vivo, the team stated, that the hematocrit (hct) values or numbers were way off from the blood gas values.The in-vivo calibrations were being done.And took several times before the unit trended closer to blood gases.The team did not exchange the unit out.There was no delay in the continuation of the surgical procedure.

Manufacturer Narrative

Updated blocks: h3 and h6 the reported complaint was not verifiable since the product was not returned for evaluation or testing.Multiple diligence attempts for part return were unsuccessful.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

Updated blocks: h3 and h6 during laboratory analysis, the product surveillance technician (pst) performed numerous in-vivo adjustments and each one was reflected accurately on the display.The monitor was turned off and set idle for eight hours, and restarted in operate mode for an extended period of time with no issues.There was no way to recreate the specific situation reported in the complaint but the issue was not duplicated.

Manufacturer Narrative

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

Manufacturer Narrative

The reported complaint could not be confirmed.The service repair technician (srt) was not able to duplicate the reported complaint.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: CARDIOPULMONARY BYPASS ON-LINE BLOOD GAS
• 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: 12273931
• MDR Text Key: 264951388
• Report Number: 1828100-2021-00262
• Device Sequence Number: 1
• Product Code: DRY
• UDI-Device Identifier: 00886799001790
• UDI-Public: (01)00886799001790(11)201118
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182110
• 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,Followup
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2020
• 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
• Treatment: BLOOD GAS ANALYZER; BLOOD GAS ANALYZER.