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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 DOUBLE HEAD PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
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LIVANOVA DEUTSCHLAND S5 DOUBLE HEAD PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 10-85-00
Device Problem Pumping Problem (3016)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/13/2021
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement.Livanova (b)(4) manufactures the s5 double head 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)(6) received a report that a s5 double head pump was giving a motor control failure error message during procedure.There was no report of patient injury.
 
Manufacturer Narrative
H10: a livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.The failure was traced back to a defective pump head.The part was replaced and problem was solved.Subsequent functional verification testing was completed without further issues and the unit was returned to service.
 
Event Description
See initial report.
 
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Brand Name
S5 DOUBLE HEAD PUMP
Type of Device
CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich
MDR Report Key11322322
MDR Text Key231675210
Report Number9611109-2021-00070
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 01/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10-85-00
Was the Report Sent to FDA? No
Date Manufacturer Received03/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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