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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP 5 (CP5) CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

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LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP 5 (CP5) CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 60-02-60
Device Problem Pumping Problem (3016)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/06/2021
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). A livanova field service representative was dispatched to the facility to investigate the device and could confirm that the display was intermittently unresponsive. The technician could not confirm the speed control knob issue. In addition, a broken connector on the processor board was identified. The touchscreen and the processor board were replaced. Subsequent functional verification testing was completed without further issues and the unit was returned to service. It cannot be ruled out that the processor board was the cause of reported issue.
 
Event Description
Livanova (b)(4) received a report that a centrifugal pump 5 (cp5) became blank during priming and the speed could not be controlled by turning the knob on the control panel. The user turned off and back on the cp5 control panel and also the complete s5 system but this could not solve the problem. There was no report of patient injury.
 
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Brand NameCENTRIFUGAL PUMP 5 (CP5)
Type of DeviceCONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstrasse 25
munich
MDR Report Key11784063
MDR Text Key280509027
Report Number9611109-2021-00246
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
PMA/PMN Number
K112225
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 04/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/06/2021
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
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/02/2021
Is This a Reprocessed and Reused Single-Use Device? No

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