MAUDE Adverse Event Report: SANMINA NEXSYS PLASMA COLLECTION SYSTEM; 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 11/26/2019

Event Type  malfunction  

Manufacturer Narrative

On november 27, 2019 haemonetics was made aware of a nexsys pcs device in which the customer's technician observed a damaged interconnect pcb with a burning smell noted.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 interconnect 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

On november 27 2019, haemonetics received a report of a nexsys pcs device which had failed the power on self test (post) protocol.The on-site technician evaluated the device and observed that a burning smell was coming from the unit, upon further inspection the technician found that the interconnect pcb had failed and required replacement.This failure had occurred during the post protocol, prior to the start of any procedure involving a donor.Haemonetics will send a replacement interconnect pcb to be installed by the on-site technician.The technician will perform the repairs necessary to replace the damaged component and will complete any calibration activities to ensure the unit meets manufacturer specifications prior to being returned to service.There was no report of injury as a result of the failed component and burning smell.The failure of this component will prevent the device from passing the post, which will prevent the device from initiating any procedures until it has been repaired and successfully completes the test protocol.

• Brand Name: NEXSYS PLASMA COLLECTION SYSTEM
• 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: 9405336
• MDR Text Key: 168914014
• Report Number: 1219343-2019-00067
• 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: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 12/03/2019

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: 11/27/2019
• Initial Date FDA Received: 12/03/2019
• 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