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 10/14/2021

Event Type  malfunction  

Event Description

It was reported that during use of the device for cardiopulmonary bypass (cpb), the blood parameter monitor (bpm) was reading the temperature inaccurately.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

Per the user facility's biomedical engineer, the arterial temperature was fluctuating around 24 degrees when patient temperature was 32 degrees.

Manufacturer Narrative

Updated blocks: b5, d9 and h3 h3 81: evaluation is in progress, but not yet concluded.

Event Description

Per clinical review: on (b)(6)2021, the team experienced a situation of temperature inaccuracy with the blood parameter monitor (bpm) during cardiopulmonary bypass (cpb).Per their biomedical engineer, the arterial temperature was reading around 24 degrees when the patient temperature was 32 degrees.The unit was changed out and the surgery was completed successfully, with no blood loss or delay.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) the monitor was powered up and put into operate mode.A multimeter with a temperature setting was set up with the probe fixed to the arterial (art) blood parameter monitor (bpm) in proximity to the thermistor.The art bpm was exposed to controlled temperatures along with the multimeter temperature probe and a comparison was made.The probe functioned as intended.The pst reviewed the erasable electronically programmable read only memory (eeprom) and there were no critical errors logged nor any standard reference sensor (srs) failure or color chip failures.

Manufacturer Narrative

The reported complaint could not be confirmed.The service repair technician (srt) could not duplicate the issue.The arterial blood parameter monitor (bpm) probe was replaced as a precautionary measure.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: 12775498
• MDR Text Key: 281682650
• Report Number: 1828100-2021-00410
• Device Sequence Number: 1
• Product Code: DRY
• UDI-Device Identifier: 00886799001790
• UDI-Public: (01)00886799001790(11)200127
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/01/2022

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/25/2021
• Initial Date FDA Received: 11/08/2021
• Supplement Dates Manufacturer Received: 12/15/2021; 01/12/2022; 03/17/2022
• Supplement Dates FDA Received: 01/05/2022; 02/03/2022; 04/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2020
• 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