Additional information has been received indicating that the prosecutor advised that they do not believe smiths medical had done anything wrong.The device is being assessed by the police and the prosecutor doesn?t see any evidence of constructional flaws and that this may change their suggestion that there might have been a missing safety mechanism.It was reported that the unit will remain in police custody until the case is done.The initial information also alleges that at this time only one death occurred.Complaint (b)(4) has the information in which indicates further details about the alleged death.(information was received from the customer that there was a crack and probably tear noted off the 3-way stopcock above the transducer.Air was reported to get into the extracorporeal membrane oxygenation (ecmo) system in which the patient was connected.Subsequently, the patient suffered a cardiovascular arrest due to an air embolism leading to resuscitation.No spontaneous return of circulation could be achieved.The dhr was reviewed on the following: lot no.3941469 (b)(4) pcs produced on 2020-02-14) - there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.No scar, ncr and no disposition of nonconforming material/parts were processed within this work order connected with stated issue.Lot no.3945140 (b)(4) pcs produced on 2020-02-21) - there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.No scar, ncr and no disposition of nonconforming material/parts were processed within this work order connected with stated issue.Lot no.3954724 (b)(4) pcs produced on 2020-03-18) - there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.Ncr no.2361 processed within this work order but not connected with stated issue.The cracks, which were found in 3 separate regions of the system, cannot be confirmed if it was an issue in which happened in the manufacturing and was shipped to sterilization and then to distribution.From the problem description is obvious, that the product was used on the patient.The damage could happen by manual handling after the priming/flushing or no priming / flushing was performed before use.).
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