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 500AVHCT

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Per subsidiary, the user entered a concentration value of k+ to recalibrate.However, the measured value could not be adjusted and an improper value was indicated on the screen.The value of k+ on the screen continued to be gray in color.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the unit did not display potassium (k+) value.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Event Description

Per clinical review: on (b)(6) 2017, the user facility clinical engineer entered a concentration value for potassium (k+) after in-vivo calibration on bypass.She stated that the measured value could not be adjusted and an improper value was displayed on the screen, along with the k+ grayed out in color, not the normal black bold color.It is not known at this point whether the clinical engineer put the k+ code into the monitor prior to bypass.The incident did not delay the surgical procedure and the patient was weaned from cardiovascular bypass (cpb) procedure without blood loss nor harm.

Manufacturer Narrative

The reported complaint was not verifiable.The device was not returned, diligence was unsuccessful in obtaining additional information.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 CORPORATION; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: katie hoyt ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 6949258
• MDR Text Key: 90402240
• Report Number: 1828100-2017-00472
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/02/2018

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: 500AVHCT
• Device Catalogue Number: 500AVHCT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/25/2017
• Initial Date FDA Received: 10/13/2017
• Supplement Dates Manufacturer Received: 10/17/2017; 12/20/2017
• Supplement Dates FDA Received: 11/10/2017; 01/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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