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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH CENTRIFUGAL PUMP 5 (CP5) CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

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LIVANOVA DEUTSCHLAND GMBH CENTRIFUGAL PUMP 5 (CP5) CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 60-01-04
Device Problem Decoupling (1145)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/12/2018
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement. Livanova (b)(4) manufactures the centrifugal pump 5 (cp5). The incident occurred in (b)(6). A livanova field service representative was dispatched to the facility to investigate the device. He tested the unit and could not reproduced the problem reported. Livanova service representative successfully performed a technical safety inspection and the unit was returned to service.
 
Event Description
Livanova received a complaint that a centrifugal pump had uncoupled from the centrifugal pump 5 (cp5) during procedure. The user stopped the pump and restarted the pump to stop the decoupling. Customer had reported that they had been in "pulse" mode coming off pump slowly and had to go back on pump when the problem had occurred. There was no report of patient injury.
 
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Brand NameCENTRIFUGAL PUMP 5 (CP5)
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 80004
MDR Report Key9680444
MDR Text Key196435321
Report Number9611109-2020-00069
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 Number60-01-04
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 Received06/12/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/31/2014
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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