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 10/12/2018

Event Type  malfunction  

Manufacturer Narrative

As per the user facility's extracorporeal membrane oxygenation (ecmo) coordinator, the problem occurred during an ecmo procedure.They cleaned the bpm, but it was still not reading accurately.All of the values on the bpm were erratic and fluctuating.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the blood parameter monitor (bpm) values were inaccurate.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 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.

Manufacturer Narrative

Per the perfusionist , there were no physical hardware/disposable issues, and no error codes.The machine was calibrated twice.The sensor was changed out twice and recalibrated each time the sensor was changed.During laboratory analysis, the product surveillance technician (pst) observed that the arterial blood parameter monitor (bpm) values remained fairly steady in operate mode with a green standard reference sensor (srs) attached.The unit was ran for 15 hours, and there was some slight drifting of the ph, carbon dioxide (co2), oxygen (o2), and potassium (k+), but no inaccuracies were determined.

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.

Event Description

Per clinical review: per the manufacturer's clinical specialist, no additional information was available at the time of this clinical review.The information available at the time of this clinical review is that during an extracorporeal membrane oxygenation (ecmo) on (b)(6) 2018, the team had blood parameter monitor (bpm) values that were off.It was not known which values the team believed were inaccurate.It was not known if the team calibrated the unit appropriately.Ecmo is an off label application for the bpm, for the product and disposables are only available for use for six hours.Information was not known at what hour on the ecmo procedure the team noticed values that were not consistent with their blood gas monitor.According to the known information, the bpm was exchanged with another one.The ecmo procedure was not delayed due to this procedure.There was no blood loss or harm associated with this 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: 8043638
• MDR Text Key: 126387424
• Report Number: 1828100-2018-00574
• 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: health professional,user faci
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/13/2019

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: 12/06/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/18/2018
• Initial Date FDA Received: 11/06/2018
• Supplement Dates Manufacturer Received: 11/15/2018; 12/06/2018; 01/07/2019; 02/07/2019
• Supplement Dates FDA Received: 12/05/2018; 12/17/2018; 01/30/2019; 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1828100-08/07/15-002-C
• Patient Sequence Number: 1