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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 500AHCT
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/20/2021
Event Type  malfunction  
Manufacturer Narrative
During laboratory evaluation, the product surveillance technician (pst) observed the unit to display a temperature significantly lower than the actual temperature. He first observed the monitor to measure the air temperature within 0. 4 celsius (c) of the actual temperature, and when connected to a shunt sensor, was within 0. 7c. He then placed the unit in a 15c environment where the measured temperature dropped quicker than expected but then stabilized. Then the unit was warmed to 30c where the measured temperature dropped from 18. 6c to 9. 6c. It was determined the measured temperature readings were fluctuating and read low relative to actual temperature.
 
Event Description
It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the blood parameter monitor (bpm) was reading a lower temperature than expected. 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.
 
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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 Key12804534
MDR Text Key281530118
Report Number1828100-2021-00422
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
Report Date 12/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number500AHCT
Device Catalogue Number500AHCT
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/23/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/05/2010
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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