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

Model Number 10-80-00

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem Death (1802)

Event Date 11/05/2014

Event Type  Death  

Event Description

Sorin group received a report that the s5 roller pump stopped during an ecmo procedure.It was reported that the pt expired five days after the event.

Manufacturer Narrative

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 received a report that the s5 roller pump stopped during an ecmo procedure.It was reported that the pt expired five days after the event.The investigation is ongoing.A f/u report will be sent when the investigation is complete.

Manufacturer Narrative

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 received a report that the s5 roller pump stopped during an ecmo procedure.A sorin service representative could not reproduce the reported issue.Numerous pressure alarms were simulated at the control threshold until the pump stopped and then the pressure was brought down until the pump resumed flow.The alarm cleared but the pump stopped following the alarm could not be reproduced.The issue of the pump stopping without alarming was also not reproduced.The serial readout showed the pump functioned according to the intended use.A preventative maintenance was performed on the unit at a later date and no issues were found.The unit has been returned to service.No further problems have been reported.No nonconformities were noted during manufacturing record review.The issue will be monitored for trends and if identified, corrections will be recommended.

• Brand Name: S5 ROLLER PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich D 809 39; GM D 80939
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich D 809 39; GM D 80939
• Manufacturer Contact: cheri voorhees, mgr ; 14401 w. 65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 4340038
• MDR Text Key: 5179499
• Report Number: 1718850-2014-00447
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-80-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2014
• Initial Date FDA Received: 12/05/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death