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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 28-95-80
Device Problems Decreased Pump Speed (1500); Increased Pump Speed (1501)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/15/2022
Event Type  malfunction  
Event Description
Livanova received a report that the control panel of a s5 mast roller pump could no longer be operated and the pump speed could not be adjusted.Reportedly, at the same time the touchscreen function froze and the switching to change from tubing /2 inch to 3/8 inch did not work.No error message was displayed.A loaner device was provided to the customer.The issue occurred during priming and there was no patient involvement.
 
Manufacturer Narrative
There was no patient involvement.Livanova deutschland manufactures the s5 mast roller pump.The incident occurred in muenchen, germany.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
 
Event Description
See initial report.
 
Manufacturer Narrative
H.10: the involved pump was manufactured in 2013 and according to the analysis of the complaints database no further similar events have been reported in the past.A livanova field service technician was dispatched to the customer facility to check and test the pump.During the visit on site: the touchscreen issue was confirmed.The touchscreen of the roller pump was found to be frozen.The issue with the tubing size which could not be changes from 1/2 to 3/8 could not be reproduced.The issue related to the not adjustable pump speed could not be reproduced.No problem was detected during the tests performed.The roller pump was found spinning properly and no components replacement was deemed necessary.Troubleshooting revealed that the touchscreen malfunction was caused by fluid ingress into the touchscreen.Most likely, the tubing size could no longer be changed because of the touchscreen issue, due to the fluid ingress into the touchscreen.Based on the results of the tests performed on site, the touchscreen malfunction is unrelated to the not adjustable pump speed.Taking into account that the speed of the pump could be properly adjusted during the tests performed by the authorized livanova field service technician, it cannot be ruled out that an intermittent issue with the processor board / intermittent communication between the processor board and the shaft encoder, solved during the reseating of the connections carried out as part of the touchscreen replacement, could have led to the reported issue.The unit was tested after the touchscreen replacement and returned to service in its expected function.
 
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Brand Name
S5 MAST ROLLER PUMP
Type of Device
CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstrasse 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 Key15182970
MDR Text Key298044977
Report Number9611109-2022-00402
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 Health Professional
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 08/08/2022
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 Number28-95-80
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/15/2022
Initial Date FDA Received08/08/2022
Supplement Dates Manufacturer Received09/16/2022
Supplement Dates FDA Received10/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/16/2013
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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