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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 Device Operational Issue (2914)
Patient Problem No Patient Involvement (2645)
Event Date 07/05/2017
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement.Livanova (b)(4) manufactures the s5 roller pump.The issue occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).The livanova field service representative who was on site performing the routine service replaced the encoder to resolve the issue.If any additional information pertinent to the reported event is received, it will be submitted in a supplemental report.Device not returned.
 
Event Description
Livanova (b)(4) received a report that the speed of the s5 roller pump could not be adjusted during maintenance.This issue was noted by a livanova field service representative during routine service.There was no patient involvement.
 
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Brand Name
S5 ROLLER PUMP
Type of Device
CONSOLE, 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 Key6799266
MDR Text Key83892150
Report Number9611109-2017-00639
Device Sequence Number1
Product Code DWB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K071318
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Medical Equipment Company Technician/Representative
Remedial Action Other
Type of Report Initial
Report Date 08/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number10-80-00
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/05/2017
Initial Date FDA Received08/16/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/06/2010
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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