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 05/20/2019

Event Type  malfunction  

Manufacturer Narrative

Per the manufacturer's subsidiary, the issue has been happening for about a month but was thought to be the shunt sensor.After changing the lot of shunt sensors the issue remained.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the partial pressure of oxygen (po2) value was unstable.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

Updated blocks: b5, d10, d11 and h3.H3: 81 evaluation is in progress, but not yet concluded (part returned).

Event Description

Per clinical review: the blood parameter monitor (bpm) was set up and calibrated without issue for a cardiopulmonary bypass (cpb) procedure on (b)(6)2019.It is unknown if the unstable value on the partial pressure of oxygen (po2) value occurred prior to the first in-vivo calibration or after the in-vivo calibration.The information available is that the po2 value was unstable before and after the in-vivo calibration.We do not know the value of the bpm reading during the suspected concern, nor the corresponding blood gas analyzer value.The team opted to exchange the bpm unit when the value was deemed unstable.There was no delay in the surgical procedure.There was no blood loss or harm associated with the event.

Manufacturer Narrative

Updated blocks: h3, h6 and h9.During laboratory analysis, the product surveillance technician (pst) could not verify the reported complaint.The data collected from the monitor with an software requirements specification (srs) attached to the arterial blood parameter monitor (bpm) indicates very little change in the partial pressure of oxygen (po2) parameter.The ro and oxygen (o2) channels track similarly to the po2 on-screen value.The service repair technician (srt) was unable to duplicate the reported complaint.He replaced the arterial bpm as a precaution.The unit operated to the manufacturer's specifications.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: 8684566
• MDR Text Key: 147515327
• Report Number: 1828100-2019-00306
• 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: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• 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: 06/12/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/09/2019
• 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.