MAUDE Adverse Event Report: INPECO SA ACCELERATOR A3600; LABORATORY AUTOMATION SYSTEM

Model Number	ACP
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the investigation, the identified root cause is that the wires of the triphasic cable on the main blindo connector were plugged with an incorrect sequence.This caused the damage of the power supplies of the modules mentioned above with the production of flames and smoke.The power supplies used in the automation system are certified for the electrical safety and the flame auto-extinguished, as expected.As consequence of this event to restore the automation system functionality, the wires of the triphasic cable on the main blindo connector have been correctly plugged and the power supplies of the involved modules have been replaced.The automation system is working according to specifications.The investigation has not highlighted any deficiency related to accelerator a3600 design.There have been no previous similar occurrences reported from the field.To avoid any re-occurrence, inpeco will test the assembled group (circuit breaker, triphasic cable and the main blindo plug) before the shipment to check the correct triphasic wiring sequence of the automation systems still in manufacturing.No further actions are foreseen.
Event or Problem Description
The event occurred during the installation of the automation system accelerator a3600 acp.480.When distributor service personnel powered on the automation system from the main electrical panel, the power supplies of several modules of the automation system were damaged.The service personnel observed flames from the electrical panel of the centrifuge module #1 and visible smoke from the electrical panels of the input output module, storage and retrieval module, centrifuge module #2, and (b)(4)interface module.The fire auto-extinguished without any intervention.Nobody present in the laboratory was injured.

• Brand Name: ACCELERATOR A3600
• Common Device Name: LABORATORY AUTOMATION SYSTEM
• Manufacturer (Section D): INPECO SA; via torraccia 26; novazzano, 6883 ; SZ 6883
• MDR Report Key: 10983931
• Report Number: 3010825766-2020-00009
• Device Sequence Number: 17034657
• Product Code: CEM
• UDI-Device Identifier: 07640172341001
• UDI-Public: (01)07640172341001(11)200921
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K121012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2020

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
• Operator of Device: Health Professional
• Device Model Number: ACP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 12/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1