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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
Device Problems Insufficient Flow or Under Infusion (2182); Pumping Problem (3016)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/01/2017
Event Type  malfunction  
Manufacturer Narrative
An analysis of the serial readout provided by the livanova field service representative was unable to confirm the reported issue. The service representative went on-site and was able to trace the failure to a software issue. The technician updated the software to resolve the malfunction. Subsequent functional verification testing was completed without further issues and the unit was returned to service. Corrective actions have been implemented for this type of issue.
 
Event Description
See initial report.
 
Manufacturer Narrative
Patient information was not provided. The model and serial number have not been provided. This information will be provided in a follow-up 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 follow-up report if made available. Livanova (b)(4) manufactures the centrifugal pump 5 (cp5). The incident occurred in (b)(6). This medwatch report is being filed on behalf of livanova (b)(4). A livanova field service representative was dispatched to the facility to investigate. The service representative performed a serial readout of the device and sent it to livanova (b)(4) for further investigation. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report. Device not returned.
 
Event Description
Livanova (b)(4) received a report that the centrifugal pump 5 (cp5) did not pump as expected and sufficient volume could not be delivered to the patient during a procedure. There was no report of patient injury.
 
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Brand NameCENTRIFUGAL PUMP 5 (CP5)
Type of DeviceCONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80939
GM 80939
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80939
GM 80939
Manufacturer Contact
joan ceasar
14401 w. 65th way
arvada, CO 80004
2812287260
MDR Report Key7153353
MDR Text Key260147407
Report Number9611109-2017-01050
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
Remedial Action Other
Type of Report Initial,Followup
Report Date 07/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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