MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CDI BLOOD PARAMETER MONITORING SYSTEM 500; MONITOR, BLOOD-GAS, ON-LINE,CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500

Model Number 500AHCT

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2018

Event Type  malfunction  

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.As per the perfusionist, the po2 on the bpm was reading 15 when it was actually 110 from the post oxygen (o2) blood gas.The bpm was calibrated twice and it made no change in the reading.Prior to switching to another device, the cell was flushed out and calibrated again but did not change the results.The bpm was being used during an extracorporeal membrane oxygenation (ecmo) procedure.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the partial pressure of oxygen (po2) on the blood parameter monitor (bpm) was reading very low.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

The reported complaint was not confirmed.The service repair technician (srt) observed the device to pass all applicable testing with no issues.The unit operated to 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.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) observed the monitor to function as expected.There were no issues encountered while performing sample functions.

Event Description

Per clinical review: during an extracorporeal membrane oxygenation (ecmo) run they had a partial pressure of oxygen (po2) reading that was 15mmhg when the arterial blood gas (abg) machine was reading 110 mmhg.For the ecmo procedure, the unit was calibrated without issue, and once initiation of ecmo occurred, the unit was in-vivo calibrated without issue.The perfusionist stated that a few days into the ecmo procedure, the po2 reading was reading 15mmhg.The team did a store recall and placed the recalled value of 110 mmhg into the machine, and then went to operate mode and the blood parameter monitor (bpm) was reading a value of 15 mmhg.They opted to then change out the shunt sensor to discern if the problem was with a shunt sensor or with the monitor.The team calibrated the shunt sensor and unit without issue.They re-established flow through the shunt sensor, and did an in-vivo calibration.The unit right after the in-vivo calibration was reading a po2 of 15 mmhg.Therefore, they exchanged the monitor and continued the ecmo without issue.All other parameters were within range during this period, and the patient was normothermic the entire ecmo.The exchange of the shunt sensor resulted in a blood loss of 1.3 milliliters (ml) of blood.There was no harm or delay in procedure due to the event.

• Brand Name: CDI BLOOD PARAMETER MONITORING SYSTEM 500
• Type of Device: MONITOR, BLOOD-GAS, ON-LINE,CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 8174595
• MDR Text Key: 131726167
• Report Number: 1828100-2018-00646
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• PMA/PMN Number: K133658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/23/2019

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: 500AHCT
• Device Catalogue Number: 500AHCT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 12/18/2018
• Supplement Dates Manufacturer Received: 12/19/2018; 03/07/2019; 04/05/2019
• Supplement Dates FDA Received: 01/11/2019; 03/29/2019; 04/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1828100-11/08/2011-026-C
• Patient Sequence Number: 1