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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 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. Serial number is unknown. This information will be provided in a supplemental report if made available. As the serial number is unknown, the device manufacture date could not be determined. This information will be provided in a supplemental report if made available. 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.
 
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Brand NameCENTRIFUGAL PUMP 5 (CP5)
Type of DeviceCONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstrasse 25
munich 80309
GM 80309
MDR Report Key11676586
MDR Text Key280506110
Report Number9611109-2021-00212
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
Remedial Action Other
Type of Report Initial
Report Date 04/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/16/2021
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 Received03/19/2021
Is This a Reprocessed and Reused Single-Use Device? No

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