• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 MAST ROLLER PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

LIVANOVA DEUTSCHLAND S5 MAST ROLLER PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 10-88-00
Device Problem Pumping Problem (3016)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/24/2020
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).Through follow up communication livanova learned that the problem had occurred at the end of the procedure and that the user replaced the pump with a backup one.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)(4) received a report that a s5 mast roller pump was giving a motor control failure error message during procedure.There was no report of patient injury.
 
Manufacturer Narrative
H.10: a review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The affected pump was requested back to the manufacturer site for investigation and repair.The reported issue could not be confirmed and the device was found to be working within specifications.Subsequent functional verification testing was completed without further issues and the unit was returned to service.Based on the fact that an hardware failure of the pump can be excluded and that the most likely root cause of the reported error was a too high pump occlusion set by the user, the reported event has been therefore re-evaluated as non reportable.
 
Event Description
See initial report.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11051072
MDR Text Key223752531
Report Number9611109-2020-00698
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 12/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 11/24/2020
Initial Date FDA Received12/21/2020
Supplement Dates Manufacturer Received02/18/2021
Supplement Dates FDA Received03/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-