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

Model Number 48-40-00

Device Problem No Audible Alarm (1019)

Patient Problem No Patient Involvement (2645)

Event Date 09/30/2015

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Device has not been returned to sorin group (b)(4).Sorin group (b)(4) manufactures the sorin s5 system.The incident occurred in (b)(4).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that the pressure alarm for the sorin s5 system did not give an audio alarm.The pressure alarm stopped the arterial pump and the visual alarm was displayed on the control panel.This issue occurred during training, so there was no patient involvement.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group (b)(4) received a report that the pressure alarm for the sorin s5 system did not give an audio alarm.The pressure alarm stopped the arterial pump and the visual alarm was displayed on the control panel.This issue occurred during training, so there was no patient involvement.

• Brand Name: SORIN S5 SYSTEM
• Type of Device: CONSOLE, HEART-LUNG-MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND GMBH; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND GMBH; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer Contact: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5243102
• MDR Text Key: 31894821
• Report Number: 9611109-2015-00534
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• 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: 10/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48-40-00
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2015
• 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