Supplemental report is being filed since investigation has been completed.Review of the device history record revealed the device was released to stock on 07/15/2020.The job router and the service records were reviewed without issues.Review of the serial number reported (15047) revealed the device passed all tests.The device was received for evaluation and tested for the issue reported "smoking, hot to the touch, and shows signs of melting.¿ temperature testing of the returned complaint pump and bench testing of aged pumps as part of the investigation revealed that the back panel temperature of a functional pump can reach between 40 and 50 degrees celsius while in operation.Temperatures measured during the testing remained within the acceptable limit of 60 degrees celsius.The device housings plastic is composed of fire-retardant material which has a 5va flammability rating at the wall thickness in the design and complies with the ul 94 standard.According to ul, 5va is the maximum flammability protection rating possible, and the key to this safety is if the device or plastic is self-extinguishing and is intended to mitigate the likelihood of a burn or fire and to reduce risk to a patient or care giver.As a result, the back panel provides significant protection against fire and the risk assessment conducted indicated that the probability of a hazardous situation leading to harm was low related to overheating.
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