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 11/05/2021

Event Type  malfunction  

Manufacturer Narrative

Per the manufacturer's subsidiary, the temperature was unstable, showing 40 degrees celsius during hypothermia.The flow rate was approximately three liters per min (l/min).About 10 minutes before the ventilator was removed, there was a noticeable difference in measurement.The bpm showed that the be was -8, while the laboratory machine showed that the be was -2.5.During cpb, the laboratory machine data was used to correct the values on the bpm.Recalibration was preformed, but there was no improvement.

Event Description

It was reported that during use of the device for cardiopulmonary bypass (cpb) the blood parameter monitor (bpm) displayed abnormal temperature and base excess (be) values.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) 2021, the team experienced a problem with the blood parameter monitor (bpm) while on cardiopulmonary bypass (cpb), whereby they noted abnormal temperature and base excess (be) values.There was no change out, no delay, no blood loss, and the surgery was completed successfully.

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

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: 12897133
• MDR Text Key: 281589273
• Report Number: 1828100-2021-00455
• 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: 11/30/2021
• 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
• 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.