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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 Appropriate Term/Code Not Available (3191)
Patient Problem No Patient Involvement (2645)
Event Date 02/01/2019
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement.Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).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 roller pump displayed an error message during training.There was no patient involvement.
 
Manufacturer Narrative
H10: the serial read-out of the pump has been provided and analyzed.The motor control failure could be confirmed.However, through the read-out analysis, the cause of the issue could not be determined.The complained unit has been requested by livanova deutschland for further investigation.A visual inspection, a functional test and an hardware analysis have been performed.The reported error could not be reproduced and no deviations have been detected.Since the issue could not be reproduced, the root cause of the error could not be identified and remains unknown.
 
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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 Key8411632
MDR Text Key138511073
Report Number9611109-2019-00149
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 04/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10-80-00
Was the Report Sent to FDA? No
Date Manufacturer Received03/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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