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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND S5 DOUBLE HEAD PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

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SORIN GROUP DEUTSCHLAND S5 DOUBLE HEAD PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 10-85-00
Device Problems Image Display Error/Artifact (1304); Failure to Pump (1502); Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/20/2016
Event Type  No Answer Provided  
Manufacturer Narrative
Sorin group (b)(4) manufactures the s5 double head pump. The incident occurred in (b)(6). This medwatch report is being filed on behalf of sorin group (b)(4). Sorin group (b)(4) received a report that the s5 double head pump displayed an error message and the pump display flickered during a procedure. There was no report of patient injury. A sorin group field service representative was dispatched to the facility to investigate. The service representative has run the pump for multiple days with no recurrence of the reported fault. 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 the s5 double head pump displayed an error message and the pump display flickered during a procedure. There was no report of patient injury.
 
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Brand NameS5 DOUBLE HEAD 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, 80939
GM 80939
Manufacturer Contact
carrie wood
14401 w. 65th way
arvada, CO 80004
3034676461
MDR Report Key5890902
MDR Text Key52612644
Report Number9611109-2016-00526
Device Sequence Number1
Product Code DWB
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K071318
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
Report Date 07/27/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10-85-00
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 Received07/27/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/17/2013
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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