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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

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LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 60-01-00
Device Problem Failure to Pump (1502)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/20/2017
Event Type  malfunction  
Manufacturer Narrative
The serial number has not been provided. This information will be provided in a supplemental report if and when made available. As the serial number has not been provided, the device manufacture date is unknown. This information will be provided in a supplemental report if and when made available. Livanova deutschland manufactures the centrifugal pump system with tubing clamp. The incident occurred in (b)(6). This medwatch report is being filed on behalf of livanova deutschland. The investigation is ongoing. A follow-up report will be sent when the investigation is complete.
 
Event Description
Livanova deutschland received a report that the centrifugal pump system with tubing clamp stopped during a procedure. The customer had to use the hand crank to continue the case. There was no report of patient injury.
 
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Brand NameCENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
Type of DeviceCONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstrasse 25
munich, 80939
GM 80939
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich, 80939
GM 80939
Manufacturer Contact
joan ceasar
14401 w. 65th way
arvada, CO 80004
2812287260
MDR Report Key6328959
MDR Text Key67396749
Report Number9611109-2017-00079
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K032213
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Biomedical Engineer
Remedial Action Other
Type of Report Initial
Report Date 02/14/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number60-01-00
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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