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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS CENTRIFUGAL SYSTEM CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS - SARNS CENTRIFUGAL SYSTEM

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS CENTRIFUGAL SYSTEM CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS - SARNS CENTRIFUGAL SYSTEM Back to Search Results
Model Number 6379
Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 08/08/2017
Event Type  malfunction  
Manufacturer Narrative
During laboratory analysis, the product surveillance technician (pst) connected a lab-use motor with an attached centrifugal head and water loop to the device under test (dut). The pst began the pump rotation at approximately 1600 revolutions per minute (rpm) and 4 l/min. Within 15 minutes, multiple resets of the dut began to occur intermittently. There were at least six reset occurrences within a two hour period. The product will be sent to service to be brought to manufacturer¿s specifications before being returned to the customer. If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The laboratory technician reported that during routine testing of the device at the service center, the unit would reset randomly while running a pump head. There was no patient involvement.
 
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Brand NameSARNS CENTRIFUGAL SYSTEM
Type of DeviceCONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS - SARNS CENTRIFUGAL SYSTEM
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
6200 jackson road
ann arbor MI 48103
Manufacturer Contact
katie hoyt
6200 jackson road
ann arbor, MI 48103
7346634145
MDR Report Key6827202
MDR Text Key247598475
Report Number1828100-2017-00391
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 company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number6379
Device Catalogue Number6379
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/20/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/19/2002
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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