According to the customer: "after priming using clear prime, cpb circuit was primed with blood.Reservoir was clogged within a few minutes of priming.Product was replaced.Treatment was delayed by 30 min." it took place during priming, no known consequences to the patient.(b)(4).
|
The set was not available for investigation.The customer had scrapped it and replaced it.Photographs are available.An investigation by maquet turkey based on the available information and the photographs concluded that the root cause of the problem could not be established as there was insufficient information concerning this complaint.A dhr review of lot 92157603 and incoming inspection reports for the filters for the reservoir in question were checked and no abnormalities were found.Additional information regarding the case was requested three times.Some answers were available on 2015-12-22 to the questions sent out, but these were not sufficient to help determine root cause.To try to establish root cause, a clinical evaluation noted that the function of unit could be impaired during operation if it was not used as intended, however no further information related to actual use is available.A review for similar complaints has been performed and only one similar incident from the same institution was found.Based on this, a confirmation of the failure based on previous complaints is not possible, and there is no systemic issue indicated.This data will be handled through a designated maquet trending process.If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.Due to this no further action will be completed at this time.
|