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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 60-02-60
Device Problem Pumping Problem (3016)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/14/2020
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 and was informed that the same issue occurred in the past. The affected device was requested for a detailed investigation at the manufacturer site. The pump serial read-out analysis revealed six "watch-dog" events which imply an automatic reset of the pump and thus the reported black screen. However, the affected pump was tested and the issue could not be reproduced during the investigation. Based on the investigation results and on the feedback provided to the service engineer by the customer, it cannot be ruled out that the multiple pump reboots had been caused by interferences in the operating theatre.
 
Event Description
Livanova (b)(4) received a report that a centrifugal pump 5 (cp5) suddenly stopped during procedure six (6) times for about five (5) seconds and the display became black. Error messages popped up on the control panel display. The device was removed from service. 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, CO 80004
MDR Report Key9842863
MDR Text Key197144112
Report Number9611109-2020-00193
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeEN
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 03/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number60-02-60
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 Received02/16/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/18/2018
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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