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 08/30/2018

Event Type  malfunction  

Manufacturer Narrative

This complaint is related to (b)(4) / medwatch #1828100-2018-00442.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the unit provided inaccurate measurements for partial pressure of carbon dioxide (pco2) and ph levels.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: it was stated to date that the perfusionist has had four different occurrences, with the most recent occurrence being (b)(6) 2018 of similar inaccuracies with the same blood parameter monitoring (bpm) system.The team calibrates their shunt sensors with gas a and gas b, along with placement of the potassium (k+) code into the monitor prior to every procedure.The team calibrates the values with the first in-vivo.The perfusionist stated that the variances of all the values (ph, pco2) are out of the accuracy specifications.During this procedure the pco2 after approximately three hours on bypass had pco2 values that were close to 40 millimeters of mercury (mmhg) off from the arterial blood gas (abg).The ph had a large delta from the abg machine also.The ph on the abg was 7.51, the bpm was reading 7.26.The pco2 on abg was 25mmhg, the bpm was reading 60 mmhg.According to the perfusionist, after the in-vivo, at the three hour mark, the unit did track the abg values much better.It was also 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 an in-vivo with all subsequent gases.Secondarily, during this procedure, the perfusionist stated that they cooled to approximately 28 degrees celsius (c).The team did not change out the monitor or 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 bpm.

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

Additional information was received from the manufacturer's clinical specialist, that the patient's ph on the arterial blood gas (abg) was 7.51 and the blood parameter monitor (bpm) was reading 7.26.The user facility has not changed the temperature drastically and always do an in-vivo with all subsequent gases.Secondarily, during this procedure, the perfusionist stated that they cooled the patient approximately 28 degrees celsius (c).

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.

• 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: 7903256
• MDR Text Key: 121725169
• Report Number: 1828100-2018-00490
• 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
• Report Date: 12/13/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/06/2018
• Initial Date FDA Received: 09/24/2018
• Supplement Dates Manufacturer Received: 10/19/2018; 12/12/2018
• Supplement Dates FDA Received: 11/09/2018; 12/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1828100-08/07/15-002-C
• Patient Sequence Number: 1
• Treatment: EPOCH BLOOD GAS ANALYZER