MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. 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 10/31/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation is in progress, but not yet concluded.

Event Description

It was reported that during extracorporeal membrane oxygenation (ecmo), the sv02 was reading between 98-100% even though the patient was actually registering 83%.This is obviously higher and did not make physiologic sense.There never were any error codes and the monitor was in vivo recalibrated at least 4 times to try and correct the venous saturation value.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.The user facility voiced concerned had the patient been weaning on ecmo support, they would have been forced to draw additional, more frequent, blood gases to assess the venous saturation.Venous saturation is the primary determinant of the patient's ability to wean from ecmo support.The additional lab tests could have caused the patient to require additional transfusion.In another cases, there may have been blood loss through additional labs.In this case it did not cause patient injury or harm because it was very early in the patient's ecmo run.Per clinical review: the cdi 500 was being used for an ecmo procedure and during start-up the color chip test successfully passed.On the initiation of ecmo, the cdi 500 was switched to the operate mode and the svo2 immediately displayed values of 98-100 %.The venous blood was darker in color and was representative of venous blood, so it was obvious to the user the 98-100 % measure was not correct.On the first in-vivo calibration, the actual lab analyzed svo2 was 83 %.The sampling site for the sample was next to the cdi 500 hsat cuvette and thus no blood mixing was involved and this was representative of venous blood.The cdi 500 svo2 was adjusted to 83% to match the lab analyzer, but when the unit was placed back to operate mode, the cdi 500 svo2 immediately jumped back to 98-100%.Later in-vivo calibration attempts yielded the same results and behavior.The ecmo manager stated, the hemoglobin and hematocrit measures of the cdi 500 (same cuvette and probe) compared reasonably well to lab analyzed values.As all cdi 500s were being utilized, no back-up monitors were available in the first 38 hours of the ecmo procedure.Some additional lab sampling was required to measure the svo2s during this period.When a back-up cdi 500 was available, the original unit was removed from the circuit and a back-up was installed (same cuvette used).Soon as the back-up unit was set to operate, the svo2 was measuring close to lab analyzed values.The procedure was successful with no delay and no associated blood loss and no harm was observed.

Manufacturer Narrative

The reported complaint was confirmed.The product surveillance technician (pst) noted that the hematocrit saturation module (h/sat) oxygen saturation (so2) value (referred in the complaint as svo2) displayed 100% despite the number of in-vivo adjustments performed.The problem was shown to be specific to the single board computer (sbc) printed circuit board assembly (pcba) as the issue was observed when the sbc was isolated and installed on the lab platter.The product will be sent to service to be brought to manufacturers specifications before being returned to the customer.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 500
• Type of Device: MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: eileen dorsey ; 6200 jackson road; ann arbor, MI 48103 ; 7347416074
• MDR Report Key: 6122111
• MDR Text Key: 60932317
• Report Number: 1828100-2016-00759
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2017

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: 11/04/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/31/2016
• Initial Date FDA Received: 11/22/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/06/2017; 01/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2006
• 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