MAUDE Adverse Event Report: HAEMONETICS CORPORATION CELL SAVER ELITE; APPARATUS, AUTOTRANSFUSION

Model Number CSE-E-US

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Date 04/22/2019

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2019 haemonetics received a reported incident of a cell saver which was observed to have a damaged centrifuge with a burning smell noted upon further inspection.On may 6 2019 a haemonetics field service engineer evaluated the device and confirmed that the centrifuge motor had failed.The fse replaced the centrifuge assembly and recalibrated the device to ensure it meets manufacturer specifications.There was no patient involved in a procedure at the time the failure was discovered.A failed centrifuge motor will prevent the device from completing the power on self test (post) protocol prior to being able to initiate any procedures.The device will detect any hardware failures and will not pass the post until the device has been repaired, preventing risk of injury to the patient as a result of hardware failure.There were no injuries reported as a result of this incident, however haemonetics has previously submitted reports of thermal decomposition observed within a device, as a result this incident is deemed reportable.

Event Description

On (b)(6) 2019 haemonetics received a reported incident of a cell saver device which was reported to have had a strange noise coming from the centrifuge motor, and when the device was evaluated in the diagnostics menu a burning smell was observed.The end user called haemonetics to schedule a service visit to evaluate and repair the affected cell saver device.There was no patient involvement at the time the burning smell was observed.No injuries have been reported as a result of the defective centrifuge assembly.

• Brand Name: CELL SAVER ELITE
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): HAEMONETICS CORPORATION; 400 wood road; braintree MA 02184
• Manufacturer (Section G): HAEMONETICS CORPORATION; 400 wood road; braintree MA 02184
• Manufacturer Contact: david ramsay ; 400 wood road; braintree, MA 02184
• MDR Report Key: 8609642
• MDR Text Key: 145032608
• Report Number: 1219343-2019-00018
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CSE-E-US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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