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 01/07/2022

Event Type  malfunction  

Manufacturer Narrative

Per the manufacturer's subsidiary,when the device was cooled, sometimes the measured temperature exceeded 40 degrees celsius (c), and sometimes it dropped to 20 degrees c.After a while, the value became normal so the end user continued to use the device.The issue had occurred multiple times.The end user checked the values using the measurements provided by the lab data each time.

Event Description

It was reported that during use of the device for cardiopulmonary bypass (cpb) the blood parameter monitor (bpm) displayed variations in the measured temperature value.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: on (b)(6) 2022, the team experienced a problem with their blood parameter monitor (bpm) whereby the temperature measured value varied inaccurately, and eventually became normal.The device was not changed out, there was no delay or blood loss, and the procedure was completed successfully.The end user stated that this situation has happened several times on this device since last summer.

Manufacturer Narrative

The reported complaint was not verifiable.The end user decided not to return the device at this time so an evaluation could not be completed.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 that the blood parameter monitor (bpm) was not abnormal during the evaluation.The probe tracked temperature consistently with a bpm on the lab use only (luo) testing equipment.The base excess (be) value depends in part on the potential hydrogen (ph), which is also affected by temperature.No unexpected temperature fluctuations were observed.It was determined that the bpm met specification.

Manufacturer Narrative

The reported complaint could not be confirmed.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: 13416979
• MDR Text Key: 289224730
• Report Number: 1828100-2022-00042
• Device Sequence Number: 1
• Product Code: DRY
• UDI-Device Identifier: 00886799001790
• UDI-Public: (01)00886799001790(11)190423
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K182110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2019
• 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.