Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 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 ROLLER PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 10-80-00
Device Problem Pumping Problem (3016)
Patient Problem No Patient Involvement (2645)
Event Date 09/25/2020
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement.Livanova (b)(4) manufactures the s5 roller 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)(4) received a report that a s5 roller pump showed issues with the direction of rotation during training.Reportedly, also an intermittent touchscreen issue occurred.There was no patient involvement.
 
Event Description
See initial report.
 
Manufacturer Narrative
H.10: the device was returned to the manufacturer site for investigation.Results confirmed the reported issue and the failure was traced back to the can cable disconnected.The device has been repaired and returned to the customer.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
S5 ROLLER PUMP
Type of Device
CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich
MDR Report Key10725953
MDR Text Key212721608
Report Number9611109-2020-00594
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 10/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10-80-00
Was the Report Sent to FDA? No
Date Manufacturer Received11/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-