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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 Power Problem (3010)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/18/2018
Event Type  malfunction  
Manufacturer Narrative
The field service representative (fsr) verified the reported complaint. There was no ac power coming through the powee entry module. The manufacturer does not have this part in stock and is an obsolete part. The user facility has been advised to remove the unit from clinical use since it is not repairable. If additional information becomes available on this complaint that would alter the facts a supplemental report will be filed accordingly.
 
Event Description
It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the unit does not run on alternate current (ac) power, only on battery. As a result an alternative device was employed. The surgical procedure was completed successfully. There was no delay, no blood loss, nor adverse consequences to the patient.
 
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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 Key7944353
MDR Text Key123259929
Report Number1828100-2018-00524
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 Other Health Care Professional
Type of Report Initial
Report Date 10/08/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/08/2018
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 Received09/18/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/27/2010
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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