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U.S. Department of Health and Human Services

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

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SORIN GROUP DEUTSCHLAND S5 MAST ROLLER PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 10-88-00
Device Problem Insufficient Flow or Under Infusion (2182)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/01/2016
Event Type  malfunction  
Manufacturer Narrative
Patient information was not provided.Sorin group (b)(4) manufactures the s5 mast 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 mast roller pump generated half the expected flow 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 reproduced the reported issue and traced the problem to an incorrectly configured dip switch on the hms and hmf board.The board was incorrectly configured during a repair in (b)(6) 2016.The dip switch was set to the correct value and subsequent testing did not identify further issues.The service representative was retrained to the procedure for this type of repair.Sorin group (b)(4) 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 the s5 mast roller pump generated half the expected flow during a procedure.There was no report of patient injury.
 
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Brand Name
S5 MAST ROLLER PUMP
Type of Device
CONSOLE, 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 Key5909020
MDR Text Key53277448
Report Number9611109-2016-00549
Device Sequence Number1
Product Code DWB
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K062396
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 08/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10-88-00
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/01/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/26/2006
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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