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 08/14/2018

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the arterial partial pressure of oxygen (po2), arterial oxygen saturation (so2), and the ph levels were out of range.The user ran manual blood gasses every 30 minutes.The surgical procedure was completed successfully.There was a 1.3 milliliters (ml) blood loss, with no delay, nor adverse consequences to the patient.Per clinical review: on (b)(6) 2018, the blood parameter monitor (bpm) was calibrated for a procedure without issue.Just prior to the initiation of cpb the end-user opened the shunt sensor to the priming solution of the cpb circuit.The ph read 8.30, partial pressure of carbon dioxide (pco2) = 13 millimeters of mercury (mmhg), po2 = 232, temperature read 28.2, and the arterial so2 read 100%.The end-user stated that he was used to seeing these types of values just prior to initiation of cpb.The team stated that the ph of the prime solution is around 7.50 ++.The values after initiation of bypass, and prior to his first in-vivo calibration were ph = 6.82, pco2 = 45, po2 = 462, bicarbonate (hco3) = 7, and base excess (be) = -25, with so2 = 100%.When the end-user went to do the first in-vivo calibration (store) the values on the bpm were ph = 6.60, pco2 = 44, po2 = 576, hco3 = 4, and arterial so2 was 100%; the arterial blood gas (abg) results were ph= 7.38, pco2 of 46 and po2 = 410.When the end-user pressed the recall on the monitor to enter these values, the bpm produced at error code in which he did not recall.The end-user stated that the ph would either not show up or read 7.5+.The po2, hco3, be and so2 numbers never came up.In addition, the end-user also stated that they try to mitigate the issue through taking the shunt sensor off the bpm and cleaned it with alcohol to remove debris and still they received arterial po2 and arterial so2 error message.The end-user repeated this removal another time, and lastly replaced the shunt sensor.All of these mitigations did not resolve the error message.It is stated in the instruction for use (ifu) to not remove the shunt sensor from the bpm after calibration, for it could affect accuracy.The incident with the bpm did not delay the continuation of the surgical procedure.There was no harm.The shunt sensor was exchanged out with an approximate blood loss of 1.3 ml.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) observed the arterial blood parameter monitor (bpm) to fail startup standard reference sensor (srs) checks.Evaluation of the inaccuracy complaint was not possible due to this failure, and instead it was evaluated using a substitute bpm from the lab platter.The on screen values could be adjusted throughout their intended operating ranges using the substitute bpm.The product was 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.

• 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: 7846945
• MDR Text Key: 119664390
• Report Number: 1828100-2018-00461
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• PMA/PMN Number: K133658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 12/10/2018

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: 500AHCT
• Device Catalogue Number: 500AHCT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/16/2018
• Initial Date FDA Received: 09/05/2018
• Supplement Dates Manufacturer Received: 11/02/2018; 12/06/2018
• Supplement Dates FDA Received: 11/19/2018; 12/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1828100-08/07/15-002-C
• Patient Sequence Number: 1