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U.S. Department of Health and Human Services

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

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LIVANOVA DEUTSCHLAND GMBH CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 60-01-00
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Patient Involvement (2645)
Event Date 07/03/2018
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement. Livanova (b)(4) manufactures the centrifugal pump system with tubing clamp. The event occurred in (b)(6). The customer canceled the service requested and the reason is unknown. No further investigation is possible thus, no issue could be confirmed and no root cause identified.
 
Event Description
Livanova received a report that during setup a centrifugal pump system with tubing clamp was giving an error code. There was no patient involvement.
 
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Brand NameCENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
Type of DeviceCONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND GMBH
lindberghstr. 25
munich 80309
GM 80309
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND GMBH
lindberghstr. 25
munich 80309
GM 80309
Manufacturer Contact
enrico greco
14401 w. 65th way
arvada, CO 80004
MDR Report Key9681436
MDR Text Key196126957
Report Number9611109-2020-00077
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeUS
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 02/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/07/2020
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 Received07/03/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/21/2004
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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