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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND S3 ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

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SORIN GROUP DEUTSCHLAND S3 ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 10-60-00
Device Problems Decreased Pump Speed (1500); Failure to Pump (1502)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/08/2016
Event Type  No Answer Provided  
Manufacturer Narrative
A livanova field representative was dispatched to investigate the issue. The replacement potentiometer was fitted. Functional tests were performed and there were no other issues reported.
 
Manufacturer Narrative
Patient information was not provided. Sorin group (b)(4) manufactures the s3 roller pump. The incident occurred in (b)(6). This medwatch report is filed on behalf of sorin group (b)(4). Sorin group (b)(4) received a report that the pump speed of the s3 roller pump intermittently dropped to zero while the user tried to fine adjust the rpm/lpm during a procedure. There was no report of patient injury. 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 the pump speed of the s3 roller pump intermittently dropped to zero while the user tried to fine adjust the rpm/lpm during a procedure. There was no report of patient injury.
 
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Brand NameS3 ROLLER PUMP
Type of DeviceCONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
SORIN GROUP DEUTSCHLAND
lindberghstr. 25
munich, 80939
GM 80939
Manufacturer (Section G)
SORIN GROUP DEUTSCHLAND
lindberghstr. 25
munich,
Manufacturer Contact
carrie wood
14401 w. 65th way
arvada, CO 80004
3034676461
MDR Report Key5931336
MDR Text Key249627565
Report Number9611109-2016-00554
Device Sequence Number1
Product Code DWB
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K950990
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 01/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/06/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10-60-00
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/19/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/28/2005
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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