This report is being submitted as follow up no.1 to provide an update to the device return date in section d9, update section h3, and to provide the completed investigation results.It was initially reported that the actual device was available for evaluation; however, it was confirmed that the device is not available.H6 - results - 3211 and 3252 is based upon the evaluation of user facility information and the provided video; 3221 is based upon no device return.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The provided video was confirmed.It was found that the blood inlet port was broken.It was also found that the cushioning material inside the unit box had a dent.Ifu states: if the product is dropped during set-up, do not use it.Replace with another device.Since the cushioning material had a dent, it was inferred that the blood inlet port was broken due to some impact load during transportation.However, the actual product could not be confirmed, and the cause of occurrence could not be clarified.With no device return the exact cause of the reported event cannot be definitively determined based on the available information.
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