Supplemental report is being filed following the submission of the initial mdr report submitted on 3/2/2021 due to the investigation findings are available.Device released from qa to stock on (b)(6) 2017.Device was serviced on (b)(6) 2019, (b)(6) 2020.Job router was reviewed without issue.Device passed all tests.Complaint overheat of device confirmed.Investigation found a loose screw inside the pump.The loose screw may have caused the pump to seize and overheat.The overheated pump melted battery wires, buttons, tubing and back panel of the enclosure.The pump malfunction prevented the performance of investigation tests.Suggest replacing pump, battery, on/off buttons, tubing and back panel of enclosure.Root cause is pump failure.Capa (b)(4) was opened and an investigation into the overheating complaints was conducted.The following corrective actions were identified to address the root causes identified in the capa.These corrective actions are planned to be completed by (b)(6) 2021.1.Ifu for sved device to be updated to include the warning for overheating and no direct contact of the device with patient.2.Update the service procedure to consider changing the motor is the motor has serviced more than 2000 hours.3.Implement the service timer recording in the service procedure and forms to determine when to change the motor once the serviceable life has been exhausted.4.Install relay cut off mechanism at appropriate threshold temperature that will cut off the current to the motor in cases when motor may draw excessive current leading to overheating effect.
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