MAUDE Adverse Event Report: SORIN GROUP USA ELECTA; APPARATUS AUTOTRANSFUSION

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 05/19/2015

Event Type  malfunction  

Event Description

Patient was having a revision of spinal implants and cell saver was requested.The machine was set up appropriately with circuit and bowl.The machine was turned on and ran a self-check and indicated that it was ready for use.The machine then started alarming noting error 19.The circuit was checked several times and the system was rebooted.This did not correct the error.The perfusionist suggested to try an new circuit.Tried new circuit and continued to have the same error code 19.The other cell saver machine was in use in the cv or.Dideco rep was called.After trying additional steps and continue having error code 19, the rep thought that it was a board issue and was not be able to complete the procedure.

• Brand Name: ELECTA
• Type of Device: APPARATUS AUTOTRANSFUSION
• Manufacturer (Section D): SORIN GROUP USA; 14401 west 65th way; arvada CO 80004
• MDR Report Key: 4956009
• MDR Text Key: 17224315
• Report Number: 4956009
• Device Sequence Number: 1
• Product Code: CAC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/23/2015

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: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/23/2015
• Event Location: Hospital
• Date Report to Manufacturer: 07/31/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/23/2015
• Patient Sequence Number: 1
• Patient Age: 19 YR