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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 ROLLER PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

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LIVANOVA DEUTSCHLAND S5 ROLLER PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 10-80-00
Device Problems Pumping Stopped (1503); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/30/2017
Event Type  malfunction  
Manufacturer Narrative
(b)46) manufactures the s5 roller pump.The incident occurred in (b)(6).This medwatch report is filed on behalf of (b)(4).The pump was returned to (b)(4) for evaluation.Visual inspection did not identify and damage or scoring caused by the magnet on the pump rolls or raceway.However, it was found that the occlusion of the pump was adjusted too high.(b)(4) determined that the cause of the issue was over-occlusion of the pump.The occlusion was correct and the pump was tested with tubing for over 24 hours without issue.A technical safety inspection was successfully completed and the pump was returned to the customer.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.(b)(4) will continue to monitor for trends related to this type of issue.
 
Event Description
(b)(4) received a report that the s5 roller pump stopped during a procedure when the pump cover magnet fell into the raceway and blocked it.There was no report of patient injury.
 
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Brand Name
S5 ROLLER PUMP
Type of Device
CONSOLE, HEART-LUNG MACHINE, 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 Key6360838
MDR Text Key68417970
Report Number9611109-2017-00106
Device Sequence Number1
Product Code DWB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K071318
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
Report Date 02/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10-80-00
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/03/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/30/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/24/2010
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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