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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO CENTRIFUGAL SYSTEM; SARNS CENTRIFUGAL SYSTEM
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TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO CENTRIFUGAL SYSTEM; SARNS CENTRIFUGAL SYSTEM Back to Search Results
Model Number 6382
Device Problem No Device Output (1435)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/12/2014
Event Type  malfunction  
Event Description
It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the flow sensor was not working as there were no readings.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 pt.
 
Manufacturer Narrative
Eval is in progress, but not yet concluded.
 
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Brand Name
TERUMO CENTRIFUGAL SYSTEM
Type of Device
SARNS CENTRIFUGAL SYSTEM
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 Key4398959
MDR Text Key5302870
Report Number1828100-2014-01135
Device Sequence Number1
Product Code KFM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K882758
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 12/12/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number6382
Device Catalogue Number6382
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/02/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/12/2014
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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