• 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 S3 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 S3 ROLLER PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 10-60-00
Device Problem Incorrect Measurement (1383)
Patient Problem No Patient Involvement (2645)
Event Date 11/27/2017
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement.Livanova (b)(4) manufactures the s3 roller pump.The incident occurred in (b)(6).The livanova field service representative who discovered the issue replaced the faulty component and subsequent functional verification testing was completed without further issues.The unit was returned to service.The replaced component has been discarded.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Evaluated on site by livanova rep.
 
Event Description
Livanova (b)(4) received a report that the potentiometer of an s3 roller pump was found to be out of tolerance during maintenance.This issue was noted by a livanova field service representative during routine service.There was no patient involvement.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
S3 ROLLER PUMP
Type of Device
CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80939
GM  80939
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80939
GM   80939
Manufacturer Contact
joan ceasar
14401 w. 65th way
arvada, CO 80004
2822287260
MDR Report Key7138862
MDR Text Key95946831
Report Number9611109-2017-01039
Device Sequence Number1
Product Code DWB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K950990
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Medical Equipment Company Technician/Representative
Remedial Action Other
Type of Report Initial
Report Date 12/21/2017
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 Other
Device Model Number10-60-00
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/27/2017
Initial Date FDA Received12/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/06/2002
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-