MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO CDI 500 BLOOD PARAMETER MONITOR

Model Number 500AVHCT

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, after running the first arterial blood gases on cpb, the displayed partial pressure of carbon dioxide (pco2) will usually be much higher than that on the point of care (poc) blood gas analyzer.After recalibrating for this discrepancy, the blood parameter monitor (bpm) seemed to over compensate and the pco2 would read very low.As such, the perfusionist (ccp) always have to run another abg immediately to recalibrate the carbon dioxide (co2).The device was not changed out, as they performed add'l blood gas analysis.The surgical procedure was completed successfully.No blood loss, although add'l blood gases were needed and no adverse consequences to the pt.

Manufacturer Narrative

Clinical summary on 07/10/2015: the ccp has noticed the partial pressure of carbon dioxide (pco2) measure of the bpm has been erratic at times since this monitor was updated with 1.69 version of software.An example, the pco2 was measuring 51mmhg after going on cpb and before during initial in-vivo calibration.When a lab sample was drawn, the actual lab measurement was 36mmhg.Sometimes the ccp will have to draw a third abg if second stored and poc values are still far apart.The bpm was adjusted to the lab result and an add'l lab sample was drawn and the bpm measure was 28mmhg and the lab measured value was 38mmhg.Add'l in-vivo calibrations were done in order to get closer agreement with the lab values.Gas flow sweeps to the oxygenator were changed (per measured bpm values) after the first in-vivo calibration as the ccp has been able to do that with 1.65 units.The case(s) was completed successfully, without delay and without associated blood loss.There was no harm observed.

Manufacturer Narrative

This complaint is related to mdr #1828100-2015-00850.During the laboratory evaluation, the product surveillance technician (pst) could not duplicate the reported issue.The blood parameter monitor (bpm) will be sent to central engineering for further testing.

Manufacturer Narrative

The reported complaint was not confirmed.The monitor met specification with no inaccuracies observed during testing in central engineering.Per the (b)(4) software upgrade, no accuracy is claimed until after gas calibration and an in-vivo calibration are performed.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: TERUMO CDI 500 BLOOD PARAMETER MONITOR
• Type of Device: CDI 500
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 4922427
• MDR Text Key: 6050686
• Report Number: 1828100-2015-00576
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 02/18/2016

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: 12/08/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2015
• Initial Date FDA Received: 06/16/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/23/2015; 02/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1828100-08/07/15-002-C
• Patient Sequence Number: 1