The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.
|
It was reported that they were trying to fill the arctic sun device and it would not take water.It also primed and stopped when they try to start therapy.Confirmed there were two bars of water.Advised they did not need to add water.Started therapy guided to system diagnostics, inlet pressure (ip) was slowly stabilized to -7.1psi (took a few minutes), circulation pump command (cpc) was (b)(4), flow rate (fr) was 3lpm, system hours were 1890, pump hours were 710.Asked if they already tried disconnecting and reconnecting the pads before calling them and they did.Advised that likely fixed the issue, patient temperature (pt) was 37.8c, targeted temperature (tt) was 37c.Explained how to properly connect pads to fluid delivery line (fdl) if they had anymore flow rate (fr) issues.
|