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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP 5; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

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LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP 5; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 60-01-04
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/22/2017
Event Type  malfunction  
Manufacturer Narrative
Patient information was not provided.Livanova (b)(4) manufactures the centrifugal pump 5.The incident occurred in (b)(6), united states.A livanova field service representative was dispatched to the facility to investigate the device.The service representative was not able to confirm the reported issue.The affected part has been replaced on precaution.Functional verification testing was completed without further issues and the unit was returned to service.The affected part was returned to livanova deutschland for a detailed investigation.The investigator could reproduce the reported issue only once even though intensive testing.As the issue could be reproduced only once, a root cause could not be determined.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.
 
Event Description
Livanova (b)(4) received a report regarding an error about fault in motor controller of centrifugal pump one on a centrifugal pump 5 occured during procedure.There was no report of patient injury.
 
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Brand Name
CENTRIFUGAL PUMP 5
Type of Device
CONTROL, 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
barbara galasso
14401 w. 65th way
arvada, CO 80004
MDR Report Key8892632
MDR Text Key175858543
Report Number9611109-2019-00631
Device Sequence Number1
Product Code DWA
UDI-Device Identifier04033817900948
UDI-Public010403381790094811160318
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112225
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial
Report Date 08/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number60-01-04
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/22/2017
Initial Date FDA Received08/14/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/23/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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