• 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 CENTRIFUGAL PUMP 5 (CP5) CONTROL, PUMP SPEED, 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 CENTRIFUGAL PUMP 5 (CP5) CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 60-02-60
Device Problem Decreased Pump Speed (1500)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/11/2021
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement. Livanova (b)(4) manufactures the centrifugal pump 5 (cp5). The incident occurred in (b)(6). The technician in charge traced the fault back to a defective shaft angle encoder which was replaced and the problem could be solved. Subsequent functional verification testing was completed without further issues and the unit was returned to service.
 
Event Description
Livanova (b)(4) received a report that a centrifugal pump 5 (cp5) was giving a shaft angle encoder failure error message and the actual rpm did not match the set rpms. The issue was identified during maintenance. There was no patient involvement.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCENTRIFUGAL PUMP 5 (CP5)
Type of DeviceCONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstrasse 25
munich 80309
GM 80309
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstrasse 25
munich 80309
GM 80309
Manufacturer Contact
enrico greco
14401 w. 65th way
arvada, CO 80004
MDR Report Key11641375
MDR Text Key244654094
Report Number9611109-2021-00193
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112225
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial
Report Date 04/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number60-02-60
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/11/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/18/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-