MAUDE Adverse Event Report: SANMINA CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM; APPARATUS, AUTOTRANSFUSION

Model Number CSE-E-CM

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Date 07/10/2018

Event Type  malfunction  

Manufacturer Narrative

On (b)(4) 2018, haemonetics received a report from a customer regarding an error code observed on their cell saver® elite® autotransfusion system.A haemonetics field service engineer was dispatched in order to troubleshoot and resolve the complaint.Upon inspection the field service engineer discovered that there was a failed integrated circuit component on the control pcb, which has been determined to have most likely failed due to a failure of the pneumatic pump assembly.The field service engineer did not observe any evidence of sparks or an open flame within the device, the burning smell was determined to have been generated from the control board pcb which had an overheating integrated circuit due to the failed pneumatics pump assembly.The field service engineer replaced the control pcb and the pneumatics pump assembly in order to resolve this issue.After replacing the failed components, the device was calibrated and tested, the unit meets all manufacturer specifications and has been returned to service as of july 18 2018.

Event Description

On (b)(6) 2018, a customer's biomed technician observed an issue with a haemonetics cell saver® elite® autotransfusion system in which there was an error message being displayed during the power on self-test protocol.A haemonetics field service engineer was dispatched to evaluate the error message and troubleshoot the potential causes.The field service engineer observed a burning odor when the device was powered on during the self-test protocol.The engineer found that the mechanical pneumatic valve assembly had failed, the failure of this mechanical subsystem in turn caused a subcomponent on the control pcb to overheat and fail, which is the most likely cause of the burning smell that was observed.The fse did not confirm any evidence of a spark or open flame within the device, as a result there was no risk of a burn injury to the device operator or technician.There was no patient involvement with this event, the issue was discovered during the power on self-test protocol and indicated via error message prior to the start of a procedure, therefore there was no risk of injury to the patient.

• Brand Name: CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): SANMINA; 202 lorong perusahaan maju 9; bukit tengah industrial park; penang, ; MY
• Manufacturer (Section G): HAEMONETICS CORPORATION; 400 wood road; braintree MA 02184
• Manufacturer Contact: christopher bailey-gates ; 400 wood rd; braintree, MA 02184 ; 7813569845
• MDR Report Key: 7732698
• MDR Text Key: 115669812
• Report Number: 1219343-2018-00023
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K120586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CSE-E-CM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2017
• 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