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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 Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement. Livanova deutschland manufactures the centrifugal pump 5 (cp5). The incident occurred in (b)(6). After first investigation, the reported error was not reproducible and an unresponsive touchscreen was detected. Afterwards, the processor board was identified to be not functional and will be replaced. According to the technician ist is likely that the board got damaged by electrostatic discharge. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
 
Event Description
Livanova deutschland received report about communication failure between the cp5 control panel and the centrifugal pump drive unit. There is no known patient involvement.
 
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Brand NameCENTRIFUGAL PUMP 5 (CP5)
Type of DeviceCONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstrasse 25
munich
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstrasse 25
munich, germany 80309
GM 80309
Manufacturer Contact
enrico greco
14401 w. 65th way
arvada, CO 80004
MDR Report Key12432579
MDR Text Key270185305
Report Number9611109-2021-00499
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K112225
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 09/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/07/2021
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? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/12/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/10/2010
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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