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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEM CORP TERUMO CENTRIFUGAL SYSTEM; SARNS CARDIOVASCULAR SYSTEM CORP

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TERUMO CARDIOVASCULAR SYSTEM CORP TERUMO CENTRIFUGAL SYSTEM; SARNS CARDIOVASCULAR SYSTEM CORP Back to Search Results
Model Number 6379
Device Problem Battery Problem (2885)
Patient Problem No Patient Involvement (2645)
Event Date 10/30/2014
Event Type  malfunction  
Event Description
It was reported that during the user of the device for a non-clinical activity, the delphin pumps used as backup for their system-1's were not holding a battery charge in the centrifugal system.There was no pt involvement.
 
Manufacturer Narrative
Evaluation is in progress, but not yet concluded.The perfusionist (ccp) was checking the unit when they found the issue.There was no pt involved.This unit is primarily used as back-up.The field service rep performed preventive maintenance (pm) inspection and confirmed the batteries were not holding a charge.He replaced the batteries and completed a release test.The unit operated to manufacturer specifications and was returned to clinical use.The suspect batteries were returned to the manufacturer for further evaluation.
 
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Brand Name
TERUMO CENTRIFUGAL SYSTEM
Type of Device
SARNS CARDIOVASCULAR SYSTEM CORP
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 Key4293299
MDR Text Key5054194
Report Number1828100-2014-00991
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K950739
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 10/30/2014
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 Number6379
Device Catalogue Number6379
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer11/17/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/30/2014
Initial Date FDA Received11/21/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/01/2003
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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