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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 Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2014
Event Type  malfunction  
Manufacturer Narrative
Eval is in progress, but not yet concluded.
 
Event Description
It was reported that during use of the device for a cardiopulmonary bypass procedure, the hematocrit (hct) reading has been inaccurate on the blood parameter monitor (bpm).The device was not changed out, blood gases drawn more frequently.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the pt.According to the ccp, in-vivo calibrations did not offer much improvements in the hct accuracies.The case was completed successfully, without associated blood loss and no delay observed.There was no harm observed.
 
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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 Key4324757
MDR Text Key56103237
Report Number1828100-2014-01030
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 faci
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/11/2014
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 Manufacturer11/20/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/11/2014
Initial Date FDA Received12/04/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/01/2013
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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