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U.S. Department of Health and Human Services

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

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CDI BLOOD PARAMETER MONITORING SYSTEM 500 MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500 Back to Search Results
Model Number 500AVHCT
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/02/2021
Event Type  malfunction  
Manufacturer Narrative
Per the perfusionist, they were about 60 minutes into a cpb procedure when some of the measured values on the bpm went missing and displayed an error. The perfusionist turned the unit off, replaced the sensors, then restarted the unit. It was then that the arterial numbers were larger than expected, and the venous numbers were different than where they were previously. The data collection system never resumed pulling the bpm data and the data had to be manually entered.
 
Event Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), the blood parameter monitor (bpm) was not sending data to the data collection system. Upon replacing the sensors and rebooting the system, the arterial measured parameters were larger than expected, and the venous measured parameters were also different than where they were previously. The surgical procedure was completed successfully. There was no delay, no blood loss, nor adverse consequences to the patient.
 
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Brand NameCDI BLOOD PARAMETER MONITORING SYSTEM 500
Type of DeviceMONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
6200 jackson road
ann arbor MI 48103
Manufacturer (Section G)
SAME
Manufacturer Contact
douglas patton
6200 jackson road
ann arbor, MI 48103
7346634145
MDR Report Key12538012
MDR Text Key273544843
Report Number1828100-2021-00345
Device Sequence Number1
Product Code DRY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133658
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 12/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number500AVHCT
Device Catalogue Number500AVHCT
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/14/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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