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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 04/16/2020
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.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.He replaced the shaft angle encoder and the issue was solved.Subsequent functional verification testing was completed without further issues and the unit was returned to service.A defective shaft encoder led to the reported event.
 
Event Description
Livanova (b)(4) received a report that a centrifugal pump 5 (cp5) speed control knob was hard to rotate and felt tight and could not go over 3.82 lpm (1615 rpm) during setup.There was no patient involvement.
 
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Brand Name
CENTRIFUGAL PUMP 5 (CP5)
Type of Device
CONTROL, 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 Key10057361
MDR Text Key194047627
Report Number9611109-2020-00305
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeUS
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 05/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number60-02-60
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/16/2020
Initial Date FDA Received05/14/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/29/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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