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 05/09/2022

Event Type  malfunction  

Event Description

It was reported that during setup of the device for a cardiopulmonary bypass (cpb) procedure, there were issues with the accuracy of the hematocrit (hct) parameter prior to in vivo calibration.An in vivo calibration was done and the device was continued to be used.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

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

Manufacturer Narrative

Per the manufacturer's engineer supervisor, the hematocrit saturation (hsat) production blood loop team used bovine blood to assess certain failure modes (e.G.Introduction of air bubbles, improper attachment of hsat probe, smudges on optical surface of the hsat probe), but upon initial review of the data, the system operated as expected (no drifting).

Manufacturer Narrative

Updated blocks: h3 and h6 per the manufacturer's engineering supervisor, testing of the blood parameter monitor (bpm) was successfully executed providing the necessary objective evidence that the performance of the complaint monitor did not match the accuracy issue described by the end user in the complaint report.However, there were unexpected behaviors from the complaint monitor.There was a spike in the hematocrit (hct) and hemoglobin (hgb) measurements.It is possible that when the cuvette was reattached to the probe, an air bubble was dislodged, causing a temporary spike in the measurements.The spike mimics the shape of spikes induced by air bubbles.It was also observed that there were continuous measurements when the probe was disconnected and reconnected to the cuvette, instead of reading 0 (% or g/dl).It is possible that there is an internal wire within the hsat probe that is loose causing false measurements.It is also possible that the magnet within the hsat cuvette associated with that probe is faulty, allowing for false measurements when the hsat probe is not connected.

Manufacturer Narrative

Updated block: h6 the reported complaint was confirmed.The service repair technician (srt) could not duplicate the reported complaint.The monitor powered on and passed self-testing successfully.The arterial blood parameter monitor (bpm) and hematocrit saturation (h/sat) probes passed service mode testing successfully.The erasable electronically programmable read only memory (eeprom) did not contain any critical errors.The srt replaced the h/sat probe as a precaution.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: 14577724
• MDR Text Key: 294235405
• Report Number: 1828100-2022-00219
• Device Sequence Number: 1
• Product Code: DRY
• UDI-Device Identifier: 00886799001790
• UDI-Public: (01)00886799001790(11)200713
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• 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: 12/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2020
• 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