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U.S. Department of Health and Human Services

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

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SORIN GROUP DEUTSCHLAND S5 ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 10-80-00
Device Problems Display or Visual Feedback Problem (1184); Image Display Error/Artifact (1304)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/11/2016
Event Type  malfunction  
Manufacturer Narrative
Patient information was not provided. Sorin group (b)(4) manufactures the s5 roller pump. The incident occurred in (b)(6). This medwatch report is being filed on behalf of sorin group (b)(4). This issue occurred as a result of user error during the touch screen repair. The customer contacted sorin group on june 10, 2016 for consultation on the repair. The customer declined on-site assistance from a sorin group field service representative and elected to replace the touch screen on their own. Sorin group (b)(4) received a report on july 12, 2016 that, following the cracked touch screen repair performed by the facility biomed, the s5 roller pump would boot up but was unresponsive and displayed warning lights rather than numbers during a procedure. This caused boot-up failures for the display tower. There was no report of patient injury. A sorin group field service representative was dispatched to the facility to investigate. The service representatve inspected the pump and discovered that the connections were in the wrong ports, causing the system to be unresponsive. This occurred as a result of the user's unfamiliarity with the touch screen replacement process. The service representative reseated the connections into the propper ports, upgraded the firmware and tested the pump per the service manual. No further issues were discovered and the unit was returned to service. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. No trend was identified for this type of issue. Sorin group deutschland will continue to monitor for trends related to this type of issue. Evaluated on site by sorin service rep.
 
Event Description
Sorin group (b)(4) received a report that, following a cracked touch screen repair performed by the facility biomed, the s5 roller pump would boot up but was unresponsive and displayed warning lights rather than numbers during a procedure. This caused boot-up failures for the display tower. There was no report of patient injury.
 
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Brand NameS5 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, 80939
GM 80939
Manufacturer Contact
carrie wood
14401 w. 65th way
arvada, CO 80004
3034676461
MDR Report Key5870480
MDR Text Key51930843
Report Number9611109-2016-00522
Device Sequence Number1
Product Code DWB
Combination Product (y/n)N
Reporter Country CodeUS
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 07/12/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/11/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10-80-00
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/12/2011
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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