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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 Problems No Display/Image (1183); Image Display Error/Artifact (1304)
Patient Problem No Patient Involvement (2645)
Event Date 02/07/2017
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement. Livanova (b)(4) manufactures the s5 roller pump. The incident occurred in (b)(6). This medwatch report is being filed on behalf of livanova (b)(4). The service representative on site for the in-service replaced the led display, which did not resolve the issue. The hkr processor board was then replaced with the new display installed and the issue was resolved. The pump parameters were re-entered and a functional check was performed before returning the device to service. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. The investigation is on-going. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report. Evaluated on site by livanova technician.
 
Event Description
Livanova (b)(4) received a report that the s5 roller pump displayed a "graphic display error" and the screen was illegible during in-service. There was no patient involvement.
 
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Brand NameS5 ROLLER PUMP
Type of DeviceCONSOLE, HEART-LUNG MACHINE, 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 Key6376533
MDR Text Key69020087
Report Number9611109-2017-00153
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
Report Date 03/03/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/03/2017
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?
Event Location No Information
Date Manufacturer Received02/07/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/25/2016
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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