MAUDE Adverse Event Report: SORIN GROUP USA SORIN; HEART/LUNG BYPASS MACHINE/ CARDIOPULMONARY BYPASS

Model Number S5

Device Problems Loss of Power (1475); Reset Problem (3019)

Patient Problem No Code Available (3191)

Event Date 03/14/2018

Event Type  Injury  

Event Description

The event is: the heart-lung machine used for cardiac bypass during open heart surgery was unintentionally shut off when the perfusionist operating the machine bumped the on/off power switch.The perfusionist immediately recognized that the pump was off and reset the switch back to on position.Although there was power to the machine, there was no forward flow of blood through the system.Additionally, the pump was unable to be manually operated to maintain effective forward flow.Circulation had to be maintained by open heart cardiac compressions for approximately twelve minutes until the back-up machine could be connected.

• Brand Name: SORIN
• Type of Device: HEART/LUNG BYPASS MACHINE/ CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP USA
• MDR Report Key: 7365858
• MDR Text Key: 103460953
• Report Number: MW5076038
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: S5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 69 YR
• Patient Weight: 92