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U.S. Department of Health and Human Services

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

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LIVANOVA DEUTSCHLAND SORIN CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 60-02-15
Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Patient Problem No Patient Involvement (2645)
Event Date 01/04/2017
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement.Sorin group (b)(4) manufactures the sorin centrifugal pump system with tubing clamp.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Through follow-up communication with the customer, sorin group(b)(4) learned that the customer tried two different flow probes on the faulty control panel before switching the panel out, confirming that the issue was with the control panel.A new flow board and cpu board have been ordered to provide to the customer as replacements.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.
 
Event Description
Sorin group (b)(4) received a report that when the customer fitted the sorin centrifugal pump system with tubing clamp to the s5 console during priming, the flow readings did not appear.A second control panel was connected, which worked as expected.The original probe was also connected to the second control panel and was found to be working properly.There was no patient involvement.
 
Manufacturer Narrative
Livanova (b)(4) manufactures the centrifugal pump system with tubing clamp.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).A new flow board and cpu board replacements were received, fitted and tested.All tests were completed without additional issues noted.As the device was not returned for investigation, the exact root cause could not be determined and corrective actions were not identified.This is a known issue; there was no patient harm reported.Livanova (b)(4) will continue to monitor for trends related to this type of issue.
 
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Brand Name
SORIN CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
Type of Device
CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
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 Key6290070
MDR Text Key66170740
Report Number9611109-2017-00013
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K032213
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 01/15/2018
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 Number60-02-15
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/04/2017
Initial Date FDA Received01/31/2017
Supplement Dates Manufacturer Received01/15/2018
Supplement Dates FDA Received01/15/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/17/2001
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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