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

Model Number CSE-EW-US

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Date 11/26/2018

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2018, a haemonetics field service engineer was installing new devices at a customer site when it was observed that a cell saver elite device was emitting a burning smell during the initial inspection/installation activities.The fse found that the suction/pneumatics system within the device was not functional after the initial power on and the burning smell was noted.The failure of the component within the device occurred prior to/during the power on self test (post) protocol.The post protocols are in place in order to test the device to ensure that there are no hardware failures prior to initiating a procedure.If the device detects any parameters out of range or a failure within the hardware components, the post protocol will fail and it will be impossible to initiate any procedures until the device has been repaired and the post protocols passed.The post is intended to prevent risk of injury to the patient and device operator that may result from a failed hardware component.Haemonetics will send a new cell saver elite device to be installed at the customer site as resolution.There were no reports of injury as a result of this component failure on the device; however, haemonetics has previously submitted medwatch reports of an observed thermal decomposition occurrence.As a result, this incident is deemed reportable.

Event Description

On (b)(6) 2018 haemonetics received a reported incident of a cell saver elite device which was observed to have a burning smell during the initial installation activities at the customer site.The haemonetics field service engineer confirmed that the burning smell was observed prior to the device completing the power on self test (post) protocol, and restarted the device.Upon restarting the device it was found that the pneumatics system was no longer functional and the device needed repair.There were no injuries reported as a result of the burning smell observed.The hardware failure occurred prior to/during the post protocol which resulted in the device failing to complete the post.Failure to successfully complete the post protocols will prevent the device from being able to initiate any procedures, the post protocol is in place in order to prevent risk of injury to the patient and device operator as a result of hardware failure.

• 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): SANMINA; 202 lorong perusahaan maju 9; bukit tengah industrial park; penang, ; MY
• Manufacturer Contact: david ramsay ; 400 wood road; braintree, MA 02184
• MDR Report Key: 8156560
• MDR Text Key: 130096284
• Report Number: 1219343-2018-00065
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CSE-EW-US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1