• 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 GMBH MAST ROLLER PUMP 85; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

  • 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 GMBH MAST ROLLER PUMP 85; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE Back to Search Results
Model Number 10-88-60
Device Problem Pumping Stopped (1503)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/26/2024
Event Type  malfunction  
Event Description
Livanova deutschland received a report that, on february 26th, at the power up, the mast roller pump 85 was running abnormally without connecting the tube.The control panel (b) detected an internal error in the motor controller was displayed (e442).Pump was rebooted and issue resolved.Accorind to used, the same issue occurred on a previous day and error log shows "no pulse block" on february 21st.There was no patient involvement.
 
Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the s5 mast roller pump, the incident occurred in japan.Investigation is ongoing.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MAST ROLLER PUMP 85
Type of Device
PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND GMBH
lindberghstrasse 25
munich 80939
GM  80939
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND GMBH
lindberghstrasse 25
munich 80309
GM   80309
Manufacturer Contact
enrico greco
14401 w. 65th way
arvada, CO 80004
MDR Report Key18968464
MDR Text Key338487834
Report Number9611109-2024-00146
Device Sequence Number1
Product Code DWB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K062396
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 02/27/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10-88-60
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/27/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/08/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-