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 Consequences Or Impact To Patient (2199)

Event Date 05/29/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the venous oxygen saturation (svo2) was experiencing abnormally high readings.As a mitigation, after cpb, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: the perfusionist reported an incident with their blood parameter monitor (bpm), occurring on numerous cases with multiple units.The units are the only ones that they had put in service.The team was waiting until their data module was available for use to put their bpms in clinical use.The bpm turned on and passed its color chip test without issue for a procedure on (b)(6)2020.The team initiated cpb and the svo2 was reading close to 100%.The team did an in-vivo and the lab value from the blood gas analyzer was quoted to be between 70 and 80%.The store/recall was performed and the bpm again throughout the case was reading close to 100%, with the patient's svo2 in the 70 and 80's.The perfusionist stated that the discrepancy of readings from actual continued throughout the entire case.Their practice is to do only one venous gas after initiation when the patient is stable.They have had no change in clinical practice or blood gas analyzers.The team exchanged their newer model bpms, and placed the older model bpms back on their heart lung machines (hlms) for clinical use.There was no blood loss, delay in surgical procedure or harm during the occurrence.

Manufacturer Narrative

The reported complaint could not be confirmed.During blood loop testing, the complaint was unable to be duplicated.All set points were achieved at 70% and 80% so2 prior to an in-vivo calibration, and set points at 70% and 80% so2 post in-vivo calibration.The set points were achieved using both 3/8 inch cuvettes and 1/2 inch cuvettes.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

As per end user, there was a 20% differences in saturation with the adult pack with 1/2 cuvette in the venous line and in the smaller pack with the 3/8 venous cuvette.In addition, the end user stated that there was no saturation offset that was set in the device settings.The service repair technician (srt) was unable to duplicate the reported issue.There were no errors or irregular values observed throughout the evaluation.The monitor operated to the manufacturer's specifications.

• 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
• MDR Report Key: 10184050
• MDR Text Key: 196083380
• Report Number: 1828100-2020-00228
• Device Sequence Number: 1
• Product Code: DRY
• UDI-Device Identifier: 00886799001790
• UDI-Public: (01)00886799001790(11)190224
• Combination Product (y/n): N
• PMA/PMN Number: K182110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• 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: 06/12/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BLOOD GAS ANALYZER; BLOOD GAS ANALYZER.