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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 Pumping Problem (3016)
Patient Problem No Patient Involvement (2645)
Event Date 04/21/2020
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement.Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).Investigation is ongoing.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 motor control failure error message occurred on a s5 roller pump when it was powered on.There was no patient involvement.
 
Event Description
See initial report.
 
Manufacturer Narrative
H.10: a field service engineer was dispatched to the facility and confirmed a motor control error.The processor board was replaced as well as the ribbon cable, speaker cable and display which are not involved in the reported issue.The most likely root cause was a defective processor board.
 
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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
MDR Report Key10079424
MDR Text Key194050386
Report Number9611109-2020-00313
Device Sequence Number1
Product Code DWB
Combination Product (y/n)N
PMA/PMN Number
K071318
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 05/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10-80-00
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/22/2020
Initial Date FDA Received05/21/2020
Supplement Dates Manufacturer Received06/04/2020
Supplement Dates FDA Received07/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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