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 Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/17/2018

Event Type  malfunction  

Manufacturer Narrative

Per the user facility's perfusionist, the blood parameter monitor (bpm) seems to come back into calibration but it takes two to three times recalibrating before it does.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the initial carbon dioxide (co2) and partial pressure of carbon dioxide (pco2) were off on several cases.The unit was recalibrated.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) observed the monitor to pass startup self-diagnostics with no failure.The monitor was placed in its service mode and a blood parameter module (bpm) standard reference sensor (srs) test was perform.The monitor's arterial bpm failed several channels which were above service mode limits of 20% to -30% for drift.The monitor was placed in its operate mode with a green srs sensor attached and was operated for over three hours, the ph and carbon dioxide (c02) values of the arterial bpm did not drift.No blood loop testing was done as the inaccuracy was a result of temperature difference.After the temperature transition, the user facility was able to stabilize the shunt.The product will be sent to service to be brought to manufacturer¿s 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.

Event Description

Per clinical review: the user facility's perfusionist stated to date that he has had three different occurrences, with the most recent occurrence being (b)(6) 2018 of similar inaccuracies.On (b)(6) 2018, the team calibrated the shunt sensors with gas a and bas b, along with placement of the potassium (k+) code into the monitor prior to every procedure.The team calibrated the values with the first in-vivo.The end-user stated that the variances of all the values (ph, partial pressure of carbon dioxide (pco2), and partial pressure of oxygen (po2)) are out of the accuracy specifications and it is taking two to three times performing in-vivo to bring the values into line with what is expected versus the blood gas analyzer.The perfusionist stated that they know their prime solution has a ph of between 7.0 and 7.8 units, and that the blood during the procedures are within that range.The team has not changed any of their clinical practices recently to have a change in what their expectations of the clinical parameter values should be.They have not changed the temperatures drastically, and always do a in-vivo with all subsequent gases.Secondarily, during these procedures, the perfusionist stated that they cool to between 28 degrees celsius (c) and 32 degrees c.The team did not change out the monitor nor the shunt sensor during the procedure.The team mitigated the questionable values by using the epoch blood gas analyzer.There was no blood loss or harm associated with the occurrences.There was no delay in the surgical procedures due to the concerns about the blood parameter monitor (bpm).

• 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: 7819988
• MDR Text Key: 118405329
• Report Number: 1828100-2018-00442
• Device Sequence Number: 1
• Product Code: DRY
• UDI-Device Identifier: 00886799001646
• UDI-Public: (01)00886799001646(11)990708
• Combination Product (y/n): N
• PMA/PMN Number: K133658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1828100-08/07/15-002-C
• Patient Sequence Number: 1
• Treatment: BLOOD GAS ANALYZER