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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 Problems Thermal Decomposition of Device (1071); Failure to Pump (1502)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/08/2018
Event Type  malfunction  
Manufacturer Narrative
Patient identifier and weight not provided. This information will be provided in a supplemental report if made available. Livanova (b)(4) manufactures the centrifugal pump system with tubing clamp. The incident occurred in (b)(6). A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report. Device not returned.
 
Event Description
Livanova (b)(4) received a report that a centrifugal pump system with tubing clamp pump did not start and after increasing the speed smoke came out of the engine during the procedure. 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
lindberghstr. 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 Key7398538
MDR Text Key104821869
Report Number9611109-2018-00869
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K032213
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 11/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/05/2018
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 Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/15/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/05/2011
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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