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 12/05/2018

Event Type  malfunction  

Manufacturer Narrative

Per the manufacturer's subsidiary, five minutes after cpb started the k+ value gradually increased and went from 4.0 to 8.0.After recalibrating the bpm, the issue occurred.K+ values from the lab were normal values.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the blood parameter monitor (bpm) had abnormal potassium (k+) values.The surgical procedure was completed successfully.There was no delay, an approximate 10 milliliters (ml) blood loss, and no adverse consequences to the patient.

Manufacturer Narrative

The reported complaint was not verifiable.Multiple diligence attempts for part return and additional information were unsuccessful.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Event Description

Further information was received that there was no blood loss during the procedure.Per clinical review: the team calibrated the shunt sensor and blood parameter monitor (bpm) without issue for a cardiopulmonary bypass (cpb) procedure on (b)(6) 2018.Five minutes after commencing cpb, before the first in-vivo calibration the potassium (k+) level on the bpm went from 4.0 to 8.0.The team performed the in-vivo calibration and the same result occurred, the value started at 4.0 and resulted at 8.0 without any known change in blood k+.According to the information available at the time of the clinical review, the blood gas analyzer value for k+ was normal (+.5 to 1.0).The team did not exchange the shunt sensor or the bpm, they relied on intermittent k+ values from the blood gas analyzer.There was no blood loss or harm associated with the incident.There was no delay in the continuation of the surgical procedure.

• 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: 8180816
• MDR Text Key: 130897490
• Report Number: 1828100-2018-00650
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• PMA/PMN Number: K123039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/27/2019

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?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: 01/08/2019; 03/07/2019
• Supplement Dates FDA Received: 01/30/2019; 03/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1828100-08/09/2010-004-C
• Patient Sequence Number: 1
• Treatment: BLOOD GAS ANALYZER