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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 Problem Battery Problem (2885)
Patient Problem No Patient Involvement (2645)
Event Date 07/17/2019
Event Type  malfunction  
Event Description
It was reported that during the use of the device for a non-clinical activity, the battery message appeared every five minutes when both switches on the centrifugal module and battery wedge were on. 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 (Section G)
SAME
Manufacturer Contact
douglas patton
6200 jackson road
ann arbor, MI 48103
7346634145
MDR Report Key8873232
MDR Text Key159869505
Report Number1828100-2019-00422
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,health
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 10/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number6379
Device Catalogue Number6379
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/18/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/20/1997
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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