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U.S. Department of Health and Human Services

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

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LIVANOVA DEUTSCHLAND S5 MAST ROLLER PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 10-88-60
Device Problem Pumping Problem (3016)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/17/2020
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement.Livanova (b)(4) manufactures the s5 mast roller pump.The incident occurred in (b)(6).Livanova initiated an 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 a s5 mast roller pump was giving a motor control failure error message during procedure.The error disappeared after switching off/on twice the pump control panel.There was no report of patient injury.
 
Manufacturer Narrative
H.10: the serial read-out of the roller pump was analyzed and the reported error message could be confirmed.It cannot be ruled out that a defective processor board had caused the problem.
 
Event Description
See initial report.
 
Event Description
See initial report.
 
Manufacturer Narrative
H.10: the affected device was returned to the manufacturer site for repair.The circuit boards were replaced to solve the reported issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The root cause of the reported issue is traceable to defective pump circuit boards.
 
Manufacturer Narrative
H.10: in the previous report the following was incorrectly reported: "the affected device was returned to the manufacturer site for repair.The circuit boards were replaced to solve the reported issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The root cause of the reported issue is traceable to defective pump circuit boards." please consider valid the statement below: " the affected device was returned to the manufacturer site for repair.The can cable connected to the processor board was replaced to solve the reported issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The root cause of the reported issue is traceable to a broken cable.Subsequent functional verification testing was completed without further issues and the unit was returned to service.".
 
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Brand Name
S5 MAST ROLLER PUMP
Type of Device
CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstrasse 25
munich 80309
GM   80309
Manufacturer Contact
enrico greco
14401 w. 65th way
arvada, CO 80004
MDR Report Key11019112
MDR Text Key221825243
Report Number9611109-2020-00688
Device Sequence Number1
Product Code DWB
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
K062396
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,Followup,Followup
Report Date 02/12/2021
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 Health Professional
Device Model Number10-88-60
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/17/2020
Initial Date FDA Received12/16/2020
Supplement Dates Manufacturer Received01/13/2021
12/01/2021
02/25/2022
Supplement Dates FDA Received02/12/2021
12/28/2021
03/25/2022
Date Device Manufactured09/14/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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