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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 60-01-04
Device Problem Pumping Problem (3016)
Patient Problem No Patient Involvement (2645)
Event Date 08/26/2020
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 review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. The involved pump was sent back to manufacturer site for investigation. Pump serial read-outs analysis revealed an error message indicating a communication failure of the can bus between cp5 panel and drive unit. The potentially involved components are the processor board, the motor control board and the connection cable. Consequently, these components are going to be replaced. Root cause of the reported event is a short on the can between cp5 panel and drive unit.
 
Event Description
Livanova (b)(4) received a report that a motor control failure error message was displayed on a centrifugal pump 5 (cp5) during operation. 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 Key10598820
MDR Text Key209374049
Report Number9611109-2020-00546
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeGM
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 09/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/29/2020
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 Received08/31/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/09/2016
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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