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 Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during use of the device for a cardiopulmonary bypass procedure, the cdi readings were off.The product was changed out.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.As per clinical review on 16-feb-2017: the cdi 500 was being used during an extracorporeal membrane oxygenation procedure (ecmo), which was outside of the intended use.In this case, the cdi 500 in question had been used for about 9 hours.Accuracy issues were in regard to hsat measures.The cdi 500 hematocrit measure was reading higher than the lab analysis measure and the svo2 measure of the cdi 500 was also higher than the lab analysis value.The cdi 500 svo2 measure was 95-100%, where the usual svo2 level was between 70-80%.Two in-vivo calibrations were completed in attempt to adjust the cdi 500 to more closely match the lab analyzed values, but no improvement in accuracy was observed.The cdi 500 monitor was changed out during the ecmo procedure, and this did not delay the procedure in any way.The case was completed successfully, without delay and without associated blood loss.There was no harm observed.

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) observed the hematocrit saturation module (h/sat) probe passed startup self diagnostics multiple times with no errors observed.The device will be moved to central engineering for blood loop testing.

Manufacturer Narrative

During blood loop analysis, the unit did not exhibit the reported inaccuracies.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

The reported complaint was not confirmed.The service repair technician (srt) observed the monitor to pass power on self-test with the alternating current power applied.The hematocrit saturation module (h/sat) passed color chip/cuvette testing in service mode and could not duplicate the complaint condition.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: 6364458
• MDR Text Key: 68783341
• Report Number: 1828100-2017-00098
• 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,Followup,Followup
• Report Date: 10/27/2017

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: 03/01/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/06/2017
• Initial Date FDA Received: 02/28/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; 08/01/2017; 10/20/2017
• Supplement Dates FDA Received: 03/24/2017; 05/09/2017; 08/25/2017; 10/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1828100-11/08/11-026-C
• Patient Sequence Number: 1