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

Model Number 48-30-00

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 07/27/2016

Event Type  Death  

Manufacturer Narrative

Patient identifier was not provided.Sorin group (b)(4) manufactures the sorin s5 system.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that a patient quickly became ill after being disconnected from the sorin s5 system following an open-heart surgical case.The surgical cardiac procedure was carried out without any problems with 110 min ecc time.After the successful disconnection of the sorin s5 system and venous canulae, the patient failed to sustain sufficient pump function.Air was detected in the left atrium of the heart and in the aortic canula.The air was removed before putting the patient back on ecc on the same s5 heart-lung machine.The patient experienced cerebral pressure the following night and expired the following day.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 a patient quickly became ill after being disconnected from the sorin s5 system following an open-heart surgical case.The surgical cardiac procedure was carried out without any problems with 110 min ecc time.After the successful disconnection of the sorin s5 system and venous canulae, the patient failed to sustain sufficient pump function.Air was detected in the left atrium of the heart and in the aortic canula.The air was removed before putting the patient back on ecc on the same s5 heart-lung machine.The patient experienced cerebral pressure the following night and expired the following day.

Manufacturer Narrative

Sorin group (b)(4) manufactures the sorin s5 system.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).A sorin group field service representative was dispatched to the facility to investigate.The service representative was not able to confirm the reported issue.A technical safety inspection of the complete sorin s5 system was successfully carried out without deviation.The system was declared fully operational.The service representative performed serial readouts for the involved arterial and cardioplegia pumps.The data was sent to sorin group (b)(4) for analysis.Analysis of the serial readout data for the arterial pump showed no hardware or software errors on the date of the event.Additionally, no faults related to the level, bubble or pressure monitoring systems were identified.Analysis of the cardioplegia pump data was not possible, as the pump was used after the event, before the service visit, and the data from the event date was overwritten.As the issue was not confirmed during the serial readout analysis, a root cause could not be determined and no corrective actions were identified.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.Evaluated on site; serial readout sent.

• Brand Name: SORIN S5 SYSTEM
• 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: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 5905461
• MDR Text Key: 53061525
• Report Number: 9611109-2016-00544
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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,Followup
• Report Date: 08/02/2016

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?: No
• Device Operator: Health Professional
• Device Model Number: 48-30-00
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2016
• Initial Date FDA Received: 08/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2007
• 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
• Patient Age: 37 YR
• Patient Weight: 81