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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 Decreased Pump Speed (1500); Pumping Stopped (1503); Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/12/2016
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). Sorin group received a report that the s5 roller pump slowed down to a stop and displayed an error message during the third cardioplegia delivery. The error was not recorded. The message was cleared and the pump was hand cranked before a restart was performed. The unit worked without issue for the rest of the procedure. There was no report of patient injury. A sorin group field service representative was dispatched to the facility to investigate. The service representative was unable to reproduce the reported fault. A serial readout was performed and the data was sent to sorin group (b)(4) for evaluation. Analysis of the pump data identified multiple over occlusion errors. This issue was the result of a user error. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. Sorin group (b)(4) will continue to monitor for trends related to this type of issue. Analysis of data logs.
 
Event Description
Sorin group (b)(4) received a report that the s5 roller pump slowed down to a stop and displayed an error message during the third cardioplegia delivery. The error was not recorded. The message was cleared and the pump was hand cranked before a restart was performed. The unit worked without issue for the rest of the procedure. 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 Key5931339
MDR Text Key54024646
Report Number9611109-2016-00572
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 08/12/2016
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 Number10-80-00
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 Received08/12/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/29/2015
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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