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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 Other (for use when an appropriate device code cannot be identified) (2203); No Flow (2991)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/11/2015
Event Type  malfunction  
Event Description
Sorin group (b)(4) received a report that the roller pump stopped during a procedure.There were no visual or audio alarms.The clinician power cycled and the pump regained flow.There was no report of patient injury.
 
Manufacturer Narrative
Sorin group (b)(4) manufactures the s5 roller pump.(b)(4).The investigation is ongoing.A follow-up report will be sent when the investigation is complete.
 
Manufacturer Narrative
Serial number should be (b)(4).Sorin group (b)(4) manufactures the s5 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 roller pump stopped during a procedure.There were no visual or audio alarms.The clinician power cycled and the pump regained flow.There was no report of patient injury.The investigation of the returned s5 roller pump ((b)(4)) could not reproduce and/or confirm the reported problem.During the electrical and functional tests as well as at the visual control of the pump, no problems or deviations could be detected.In a test run of about 100h with different interventions, master/follower function and rotational speeds under pcan-monitoring (monitoring of the direct data communication via can-bus), no problems or deviations could be detected.Although the problem could not be reproduced and no faults could be detected, we recommend the hkr 0325 processor board (item-no.90-305-620) and software version be updated to current manufacturing standards.This recommendation is based on sorin group standard manufacturing practice for returned units.A review of the dhr could not identify any concessions, deviations and nonconformities relevant to the reported failure.The root cause could not be determined, but this issue will be monitored for trends and if a trend is identified, corrective action will be recommended.
 
Event Description
Sorin group (b)(4) received a report that the roller pump stopped during a procedure.There were no visual or audio alarms.The clinician power cycled and the pump regained flow.There was no report of patient injury.
 
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Brand Name
S5 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
cheri voorhees
14401 w. 65th way
arvada, CO 80004
3034676527
MDR Report Key4913605
MDR Text Key6056426
Report Number9611109-2015-00231
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,health professional
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial
Report Date 08/20/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10-80-00
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/21/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/11/2015
Initial Date FDA Received07/10/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/14/2005
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Congenital Anomaly;
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