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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 Problem Pumping Stopped (1503)
Patient Problem Infarction, Cerebral (1771)
Event Type  Death  
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.
 
Manufacturer Narrative
The results of the investigation at the manufacturer site revealed that the issue could not be reproduced.The device was found to be working within specifications.
 
Event Description
See initial report.
 
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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
MDR Report Key8780505
MDR Text Key150702197
Report Number1718850-2019-01011
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial,Followup
Report Date 06/14/2019,09/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/14/2019
Device Age8 YR
Event Location Hospital
Date Report to Manufacturer06/14/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/11/2019
Supplement Dates Manufacturer Received06/14/2019
Supplement Dates FDA Received09/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death; Required Intervention;
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