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

MAUDE Adverse Event Report: LIVANOVA DEUTCHSLAND SORIN CENTRIFUGAL PUMP 5 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 DEUTCHSLAND SORIN CENTRIFUGAL PUMP 5 CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 60-01-04
Device Problems No Display/Image (1183); Failure to Pump (1502)
Patient Problem No Patient Involvement (2645)
Event Date 02/11/2016
Event Type  malfunction  
Manufacturer Narrative
This is a follow up to the initial mdr submitted. After further investigation, it was determined the reported issue could be reproduced and it was caused by a short circuit at the soldering joints of one component which led to the failure of 2 other components on the motor control pcb zpr 0801. After resoldering of these 3 components no further issues were identified during testing. Corrections were made to manufacturer, mfr site to reflect manufacturer name change and updated contact information.
 
Manufacturer Narrative
There was no patient involvement. Sorin group (b)(4) manufactures the sorin centrifugal pump 5 (cp5). The incident occurred in (b)(6). This medwatch report is filed on behalf of sorin group (b)(4). Sorin group received a report that the sorin centrifugal pump 5 did not display values and the centrifugal pump did not turn when the unit was ramped up during priming. There was no patient involvement. A sorin group field service representative was dispatched to the facility to investigate and was able to reproduce the reported issue. A new drive unit was resolved and a functional verification was performed. No further issues were found and the unit was returned to service. The replaced device has been requested for further investigation. A follow-up report will be sent when the investigation is complete.
 
Event Description
Sorin group (b)(4) received a report that the sorin centrifugal pump 5 did not display values and the centrifugal pump did not turn when the unit was ramped up during priming. There was no patient involvement.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSORIN CENTRIFUGAL PUMP 5
Type of DeviceCONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTCHSLAND
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
2812287260
MDR Report Key5488106
MDR Text Key250204179
Report Number9611109-2016-00119
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
Remedial Action Other
Type of Report Initial,Followup
Report Date 11/02/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/08/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number60-01-04
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/11/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/02/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-