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

Model Number S5

Device Problems Device Alarm System (1012); Over-Sensing (1438); Failure to Sense (1559)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/23/2015

Event Type  malfunction  

Event Description

The arterial line pressure is set to stop at 360mmhg on the heart lung machine (hlm) pressure module.By the time the pump actually stops the transducer pressure is measuring at 670 - 700mmhg, and can go even higher during a case when the pump's rpm is set even higher.There is an inherent delay in response time from when the hlm senses the overpressure and then when the pump actually stops.Setting the occlusion rate can be frustrating because as the clinician changes the occlusion it can take several seconds for the reading to respond.Likewise, when the arterial alarm limit is exceeded it takes a moment for the pump to stop, which allows for the over pressure.This response happens 100% of the time and is entirely predictable.We purchased the new s5 systems last spring and perfusionists state the older s3 systems had a much better reaction time.The issue has been addressed with the sorin sales representative and also the regional service manager but there has been no support from sorin on the problem.We have seen one instance of an occluded arterial line bursting from over pressure; fortunately the patient was not adversely affected.This happens 100% of cases (nothing about the specific patient).

• Brand Name: S5
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP; 14401 west 65th way; arvada, CO 80004
• MDR Report Key: 4557211
• MDR Text Key: 22268045
• Report Number: 4557211
• Device Sequence Number: 1
• Product Code: DTQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/12/2015

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: Invalid Data
• Device Model Number: S5
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/12/2015
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2015
• Patient Sequence Number: 1