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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 Unexpected Shutdown (4019)
Patient Problem No Patient Involvement (2645)
Event Date 01/24/2020
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement. Serial number is unknown. This information will be provided in a supplemental report if made available. As the serial number is unknown, the device manufacture date could not be determined. This information will be provided in a supplemental report if made available. Livanova (b)(4) manufactures the centrifugal pump (cp5). The incident occurred in (b)(6). A livanova field service representative was dispatched to the facility to investigate the device and could not reproduce the reported issue. The machine was working properly and was put back into service. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
 
Event Description
Livanova (b)(4) received a report that the control panel of a centrifugal pump system became blank and pump shutted off during priming and the pump started alarming with the message "cp5 shutdown due to prolonged cardioplegia usage". The user turned the cp5 control panel off and on and the display would not come back on. The customer did not use the pump during the case. The machine was put aside by the customer and left running for 4 hours without a repeat of the issue. 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 GMBH
lindberghstr. 25
munich
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80309
GM 80309
Manufacturer Contact
enrico greco
14401 w. 65th way
arvada, CO 80004
MDR Report Key9737544
MDR Text Key197141163
Report Number9611109-2020-00121
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,Followup,Followup
Report Date 02/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/21/2020
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 Received09/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/06/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

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