MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEM 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 Date 04/20/2015

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass procedure, the user received the wrong ph reading on the blood parameter monitor (bpm).The device was not changed out, as they continued to use for the case.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

Per the subsidiary site it is their understanding through the distributor, that the in-vivo calibration was not done, hence the inaccuracy.Per manufacturer clinical services, briefly looking at bpm data, it looks like the bpm and the laboratory analyzer were in different temperature modes.One was in the 37 degrees celsius mode and one was in the "@" temperature mode.If the laboratory analyzer is analyzing the blood sample at degrees celsius then the bpm needs ot be in the 37 degree mode (upper right corner toggle).If the laboratory analyzer is correcting the blood gas to the actual patient temperature, then the bpm must be in the "@" mode.The unit will not be sent in for repair unless necessary.The subsidiary site is still trying necessary steps to resolve the issue to rule out user errors.

Manufacturer Narrative

The reported complaint was confirmed.Initial information from the manufacturer's subsidiary and clinical review indicated the inaccuracies may be due to either not performing in-vivo calibrations or having the monitor and lab analyzer in different temperature settings.The subsidiary received confirmation that when the perfusionist started performing in-vivo calibrations the unit would work correctly.No additional action will be taken at this time.

• Brand Name: TERUMO CDI 500 BLOOD PARAMETER MONITOR
• Type of Device: CDI 500
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEM CORP.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 4774502
• MDR Text Key: 5805536
• Report Number: 1828100-2015-00413
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K972962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative,company repres
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/25/2015

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2015
• Initial Date FDA Received: 05/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1828100-08/09/2010-004-C
• Patient Sequence Number: 1