MAUDE Adverse Event Report: SANMINA NEXSYS PCS; SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC

Model Number PCS-300-US

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Date 08/22/2018

Event Type  malfunction  

Manufacturer Narrative

On december 20 2018 haemonetics was made aware of a nexsys pcs device in which the customer's technician observed a damaged pneumatics pcb with a burnt component visible on the pcb.The customer's technician evaluated the device and did not find any other damaged components, and has ordered a replacement component to be sent for resolution.Haemonetics has sent a replacement pneumatics pcb to be installed by the on-site technician, who will also ensure 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

Haemonetics was notified of a nexsys pcs device which was observed to have a burning smell during the device start up inspection and power on self test (post) protocol.The on-site technician observed a burnt component on the pneumatic pcb, and confirmed that the pneumatics pcb had failed during the start up test.The customer did not report any injuries experienced by the technician, this failure occurred prior to any donor/patient involvement with the device and procedure.The failure had occurred prior to the completion of the post protocol, preventing the device from initiating any plasmapheresis procedure.

• Brand Name: NEXSYS PCS
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
• 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: 8199303
• MDR Text Key: 131496390
• Report Number: 1219343-2018-00071
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK180185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 12/27/2018

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: Other
• Device Model Number: PCS-300-US
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/20/2018
• Initial Date FDA Received: 12/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2018
• 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