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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO CDI 500 BLOOD PARAMETER MONITOR
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TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO CDI 500 BLOOD PARAMETER MONITOR Back to Search Results
Model Number 500AHCT
Device Problems Device Alarm System (1012); Smoking (1585)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/10/2014
Event Type  malfunction  
Event Description
It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the blood parameter monitor (bpm) would not power on totally, then it would alarm and the screen would go blank.The customer also noted a burning smell.As a result, an alternate device was employed.The surgical procedure was completed successfully.There were no delays, no blood loss, or no adverse consequences to the pt.
 
Manufacturer Narrative
Evaluation is in progress, but not yet concluded.
 
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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 Key3818629
MDR Text Key17997176
Report Number1828100-2014-00220
Device Sequence Number1
Product Code DRY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K972962
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
Report Date 03/10/2014
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 Number500AHCT
Device Catalogue Number500AHCT
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/17/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/10/2014
Initial Date FDA Received04/02/2014
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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