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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 10-88-00
Device Problem Component Missing (2306)
Patient Problem No Patient Involvement (2645)
Event Date 10/16/2018
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement.Livanova (b)(4) manufactures the s5 mast 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 the magnet of a s5 mast roller pump cover was missing during setup.There was no patient involvement.
 
Manufacturer Narrative
Livanova field service representative was dispatched onsite to investigate.The reported issue could be confirmed.The pump cover was replaced with a new one and subsequent functional verification testing found no further issues.The device was returned to service.A review of the dhr did not identify any deviations or non-conformities relevant to the issue.A corrective action was implemented for that issue.
 
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Brand Name
S5 MAST ROLLER PUMP
Type of Device
CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich
MDR Report Key8068108
MDR Text Key128601359
Report Number9611109-2018-01332
Device Sequence Number1
Product Code DWB
Combination Product (y/n)N
PMA/PMN Number
K062396
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 12/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10-88-00
Was the Report Sent to FDA? No
Date Manufacturer Received12/03/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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