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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 Stopped (1503)
Patient Problem Infarction, Cerebral (1771)
Event Type  malfunction  
Manufacturer Narrative
Patient information was not provided. The date of event has not been provided yet. If this information is provided it will be provided in a supplemental report. Livanova (b)(4) manufactures the centrifugal pump 5 (cp5). The incident occurred in (b)(6). A livanova field service representative was dispatched to the facility to investigate but he could not reproduce the reported failure. He tested the unit and it was working within specifications. However, under customer request, a new device was installed. Through follow-up communication with the technician in charge, livanova (b)(4) learned that the patient did suffer a stroke during the surgery. It is unclear as to whether the incident could be or not a contributing factor of the stroke. Patient was transferred from icu and is recovering from the negative symptoms. The serial read-out of the pump has been collected and the affected device was requested back to the manufacturer site for a detailed investigation. 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 display of a centrifugal pump 5 (cp5) became blank and the device stopped working during the procedure resulting in blood having a dark color. The surgeon decided to abort the bypass and to end the procedure prematurely.
 
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Brand NameCENTRIFUGAL PUMP 5 (CP5)
Type of DeviceCONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 89309
GM 89309
Manufacturer Contact
enrico greco
14401 w. 65th way
arvada, CO 80004
MDR Report Key8780364
MDR Text Key150695834
Report Number9611109-2019-00527
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
Report Date 09/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received08/16/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/12/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 07/11/2019 Patient Sequence Number: 1
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