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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

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LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 60-01-00
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Patient Involvement (2645)
Event Date 11/21/2018
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement.Livanova (b)(4) manufactures the centrifugal pump system with tubing clamp.The incident occurred in (b)(6).If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
 
Event Description
Livanova (b)(4) received a report that a centrifugal pump system with tubing clamp displayed error messages during set-up.There was no patient involvement.
 
Event Description
See initial report.
 
Manufacturer Narrative
A livanova field service representative was dispatched to the facility to investigate.The service representative was able to confirm the reported issue and traced the failure to defective device.The technician replaced the erc clamp to resolve the reported issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The defective device was requested back to livanova deutschland for further investigation.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
 
Event Description
See initial.
 
Manufacturer Narrative
The device was returned livanova deutschland for further investigation.During the evaluation the reported issue could be confirmed and reproduced.Fluid ingress inside the clamp could be identified as root cause for the reported issue.This is a known issue and livanova deutschland implemented corrective actions to solve the reported issue.
 
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Brand Name
CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
Type of Device
CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich
MDR Report Key8178430
MDR Text Key131342246
Report Number9611109-2018-01420
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
PMA/PMN Number
K032213
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Other
Type of Report Initial,Followup,Followup
Report Date 06/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number60-01-00
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/21/2018
Initial Date FDA Received12/19/2018
Supplement Dates Manufacturer Received02/28/2019
05/21/2019
Supplement Dates FDA Received03/28/2019
06/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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