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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

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LIVANOVA DEUTSCHLAND S5 ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 10-80-00
Device Problem Image Display Error/Artifact (1304)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/04/2018
Event Type  malfunction  
Manufacturer Narrative
Livanova (b)(4) manufactures the s5 roller pump. The event occurred in (b)(6). A livanova field service representative was dispatched to the facility to investigate. The service representative was able to confirm the reported issue and upgraded the touch screen from an lcd to an led display. Subsequent functional verification testing did not identify further issues and the unit was returned to service. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. 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 an s5 roller pump experienced a graphic display failure during a procedure. There was no report of patient injury.
 
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Brand NameS5 ROLLER PUMP
Type of DeviceCONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80039
GM 80039
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 Key7559090
MDR Text Key109774864
Report Number9611109-2018-01013
Device Sequence Number1
Product Code DWB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071318
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 08/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10-80-00
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/25/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/11/2009
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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