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

Model Number 48-40-00

Device Problem Pumping Stopped (1503)

Patient Problem Death (1802)

Event Date 03/19/2015

Event Type  Death  

Event Description

Sorin group (b)(4) received a report that the sorin s5 system displayed error messages and the pump stopped during a procedure.The patient expired later in intensive care.

Manufacturer Narrative

The patient identification and weight were not provided.Sorin group (b)(4) manufactures the s5 system.The system includes components: cp5 60-02-60, sn (b)(4); 60-01-04, sn (b)(4); pump 10-80-00, sn (b)(4);and 10-85-00, sn (b)(4).The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

• Brand Name: SORIN S5 SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindbergh strasse 25; munich 8093 9; GM 80939
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND; lindbergh strasse 25; munich 8093 9; GM 80939
• Manufacturer Contact: cheri voorhees, manager ; 14401 w 65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 4707431
• MDR Text Key: 5662463
• Report Number: 9611109-2015-00099
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Unknown
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/19/2015

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 Number: 48-40-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2015
• Initial Date FDA Received: 04/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2012
• 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: 75 YR