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U.S. Department of Health and Human Services

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

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LIVANOVA DEUTSCHLAND 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 Patient Involvement (2645)
Event Date 01/08/2020
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). As per cp_ifu_60-00-60, the reported "no monitoring/control centrifugal pump" error messages indicate that the connection between the monitoring device (i. E. Level, bubble, flow monitoring function activated) and the cp5 is interrupted. This error message correctly appeared because when the cp5 goes off , the connection to the monitoring function is compromised. Based on the information provided, the problem could be easily managed and solved by the operator re-starting the system. The affected device has been requested for investigation at the manufacturer site. The issue could not be reproduced during functional tests, however the analysis of the serial read out of cp5 panel revealed that a can interruption error message was stored on the date of event reported. Thus, a communication interruption between the s5 system panel and the cp5 panel occurred. The root cause of the can interruption remain unknown however an involvement of the processor board which will be replaced, cannot be ruled out.
 
Event Description
Livanova (b)(4) received a report stating that a cp5 control panel display became black and the control panel showed no pump monitoring/control during priming. The s5 was turned off and back on and all failures could be solved. However, the control panel of the cp5 was replaced with another before starting the case. There was no patient involvement.
 
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Brand NameCENTRIFUGAL PUMP 5 (CP5)
Type of DeviceCONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80309
GM 80309
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80309
GM 80309
Manufacturer Contact
enrico greco
14401 w. 65th way
arvada, CO 80004
MDR Report Key10300370
MDR Text Key199751607
Report Number9611109-2020-00428
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeUK
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 07/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/21/2020
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 Received06/23/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2017
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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