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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEM CORP. TERUMO CDI 500 BLOOD PARAMETER MONITOR
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TERUMO CARDIOVASCULAR SYSTEM CORP. TERUMO CDI 500 BLOOD PARAMETER MONITOR Back to Search Results
Model Number 500AHCT
Device Problem Charred (1086)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/22/2014
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 turn on.The bpm doesn't make any noise but the power light emitting diode (led) on the switch does illuminate.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.
 
Manufacturer Narrative
Per the laboratory evaluation, the produce surveillance technician (pst) found capacitor (c106) charred and burnt.
 
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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 Key4494311
MDR Text Key5500266
Report Number1828100-2015-00114
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 Biomedical Engineer
Type of Report Initial
Report Date 02/05/2015
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 Number500AHCT
Device Catalogue Number500AHCT
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/02/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/05/2015
Initial Date FDA Received02/05/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2003
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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