The affected safestar 55 was available for investigation.The reported blockage/occlusion could be confirmed.An isolated manufacturing failure was identified as the root cause.During the manufacturing process glue is applied to fix the filter medium inside the housing.It cannot be completely avoided that excessive glue causes an occlusion of the filter medium.In order to detect occlusions the manufacturing process of the safestar 55 includes an automatic 100% resistance test including and an automized destruction of those parts which fail the test.Based on the analyses performed at supplier site, this particular case could be attributed to a maintenance of the production equipment.During the time of the maintenance (first week in march 2021), the manufacturing process was performed in a manual mode, in which the automatic destruction routine is not active.As a result, this occluded filter was not scrapped and finally shipped.The supplier has already performed addtional training of the relevant staff to ensure that the automatic process must be followed at any time.Based on the numbers of devices sold and the estimated time periods for delivery and usage, dräger concludes that safestar 55, manufactured during this particular week in march 2021, are no longer in the market.The instructions for use contain a corresponding warning: ¿risk of malfunction obstructions, damage and foreign matter can lead to malfunction.Check all system components for obstructions, damage, and foreign matter before installation¿ in case completely occluded safestar 55 is put into operation anyway, the patient cannot be ventilated.This will be readily apparent for the user by means of the main device¿s pressure and flow and fio2-monitoring.Corresponding alarms will be generated.
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