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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 48-40-00
Device Problem No Audible Alarm (1019)
Patient Problem No Patient Involvement (2645)
Event Date 11/27/2019
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement.The field service representative replaced the motor end stage board hmf 0408 and subsequent functional verification testing found no further issues.The issue was solved and the device was returned to service.A review of the dhr did not identify any deviations or nonconformities relevant to the issue.
 
Event Description
Livanova (b)(4) received a report that rotating the pump rotor manually in the direction opposite to the operational one when a s5 roller pump was off, no alarm sounded.This was identified by a livanova field service representative during maintenance.There was no patient involvement.
 
Event Description
See initial report.
 
Manufacturer Narrative
H.10: a review of the dhr could not identify any deviations or nonconformities relevant to the issue.The part was requested for further investigation at the manufacturer site.Results revealed that the buzzer on the motor power amplifier was not working therefore no alarm sound was emitted.
 
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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 Key9522929
MDR Text Key177423572
Report Number9611109-2019-01003
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 02/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number48-40-00
Was the Report Sent to FDA? No
Date Manufacturer Received01/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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