The device was not returned for evaluation.No lot number was provided; therefore, no dhr review is possible.Three (3) photos were provided, each attributed to a different complaint - mfg report numbers: this report, 2648988-2018-00048, and 2648988-2018-00049, but they are of the same device.Therefore, only one complaint (this report) will be confirmed based on the photos provided.A leak was reported from the patient line stopcock (proximal to the patient).Patient line stopcock is component p/n 200407-001 of which each accudrain unit has two (2) of them (patient line, and zero reference stopcocks).Only the patient line stopcock was reported as leaking.All stopcocks are visually inspected prior assembly, and each assembled patient line is leak tested during the manufacturing process to prevent this type of defects.The complaints explain that the devices were in use for several weeks prior to breakage (32, 28, and 17 days respectively).They also state that one of the patients was also receiving ¿intrathecal abx¿ and was clamped and unclamped multiple times a day.In another patient the drain system fell off the pole and certainly could have damaged the line.Also, eeg removal spray was used, apparently in at least two of them.This type of spray may have chemicals that could make the stopcock material brittle.No further evaluation is possible at this moment.Linked to mfg number: 2648988-2018-00048 and 2648988-2018-00049.
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