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

Model Number 500AHCT

Device Problem High Readings (2459)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2015

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass procedure, the blood parameter monitor (bpm) reading for ph was excessively high right after going on pump.The device was not changed out, as they continued to use for the care.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the pt.Per the clinical review on (b)(6) 2015: since this bpm unit software was updated from 1.67 to 1.69, they have noticed that prior to the first in-vivo calibration the ph and partial pressure of carbon dioxide (pco2) are reading very high.These very high values continue until the in-vivo calibration is completed.This behavior is different than seen with previous 1.65 version of software.The perfusionist (ccp) stated they have not changed their prime solution and/or not changed their prime solution and/or not changed additives to the prime (e.G sodium bicarbonate dosage).They have not changed clinical practice and this unit, as always, was gas calibrated prior to use and the calibration was successful.After the initial in-vivo calibration is completed and thus adjusted to the laboratory analyzed values, the ph and pco2 closely follow laboratory analyzed values.These unexpected values are detected as not accurate by the clinical team.The case was completed successfully, without delay and without associated blood loss.There was no harm reported.

Manufacturer Narrative

This complaint is related to mdr #1828100-2015-00468.

Manufacturer Narrative

The reported complaint was confirmed.Per the 1.69 software upgrade, no accuracy is claimed until after an in-vivo calibration is performed.Per diligence with the customer, they found that the upgrade changed their calibration settings, and after that was corrected they had no more issues.No product will be returned to the manufacturer.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: 4840694
• MDR Text Key: 5872866
• Report Number: 1828100-2015-00469
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972962
• 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
• Report Date: 06/08/2016

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: 500AHCT
• Device Catalogue Number: 500AHCT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2015
• Initial Date FDA Received: 06/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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