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

Model Number CSE-E-CM

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Date 04/30/2019

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2019, haemonetics was made aware of a cell saver elite device in which a field service engineer observed a damaged user interface pcb with a burning smell noted.The field service engineer evaluated the device and did not find any other damaged components, and has ordered a replacement component to be sent for resolution.The haemonetics has installed a replacement ui pcb and ensured that the device is calibrated and meets all specifications prior to being returned to service.There was no donor involved in the procedure when this failure was detected.This failure had occurred during the power on self test (post) protocol.The device must pass the post protocol prior to being able to initiate a device and introduce a donor to complete a procedure.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 donor as a result of a 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 was made aware of a cell saver elite machine which had failed when powered on.When the device was evaluated by a field service engineer, a burnt electronic smell was observed and burn marks were found on a component on the user interface pcb.There were no injuries reported as a result of the component failure.No donor or patient involvement with the machine at the time of failure.The failed ui pcb prevented the device from initiating and completing the power on self test (post) protocol.

• Brand Name: CELL SAVER ELITE
• 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: 8668365
• MDR Text Key: 146980743
• Report Number: 1219343-2019-00023
• 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: user facility
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• 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: 05/06/2019
• Date Manufacturer Received: 05/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2017
• 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