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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 BYPASSDWB

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LIVANOVA DEUTSCHLAND S5 MAST ROLLER PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASSDWB Back to Search Results
Model Number 10-88-60
Device Problem Increased Pump Speed (1501)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/15/2020
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).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.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 an error message related to increased pump speed during procedure.There was no report of patient injury.
 
Event Description
See initial report.
 
Manufacturer Narrative
H.10: the unit was returned to manufacturer site for repair.The pump head was found blocked and could not be rotated.Dirty and traces of blood could be found on the device.The pump was cleaned and disinfected.The processor board and flat ribbon cable were replaced.Other components were replaced as well due to traces of use.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The most likely root cause of the reported issue is a defective processor board/flat ribbon cable.
 
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Brand Name
S5 MAST ROLLER PUMP
Type of Device
CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASSDWB
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 Key10834570
MDR Text Key216094884
Report Number9611109-2020-00630
Device Sequence Number1
Product Code DWB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K071318
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
Report Date 10/15/2020
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 10/15/2020
Initial Date FDA Received11/13/2020
Supplement Dates Manufacturer Received10/28/2021
Supplement Dates FDA Received11/26/2021
Date Device Manufactured10/09/2014
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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