Patient code: vascular system (circulation), impaired device code: no known device problem method code: actual device not evaluated method: the device was reported as not available for return and analysis.The reporter was unable to provide a lot number; thus, the device history record (dhr) review cannot be conducted.Results: as the device and lot number were unavailable for analysis, no methods were performed.For this reason results cannot be obtained.Although the exact model pump and catheter was unknown, the instructions for use (ifu) for on-q catheters and introducers ((b)(4)) and an on-q pump with fixed flow rate ((b)(4)) specify the following: "avoid placing the catheter in the distal end of extremities (such as fingers, toes, nose, ears, penis, etc.) where fluid may build up as this may lead to ischemic injury or necrosis." "avoid tight wrappings which can limit blood supply or fluid diffusion." "due to risk of ischemic injury, vasoconstrictors such as epinephrine are not recommended for continuous infusions for the following routes of administration: intraoperative site, perineural and percutaneous (excluding epidural).Conclusions: the device was not returned to halyard for evaluation, therefore we are unable to determine the cause for the reported event.Limited information was provided by the reporter.Multiple attempts were made to obtain additional information without success.Based on the limited information, it cannot be determined if user/facility conditions may have caused or contributed to the reported incident.Therefore, the assignable cause could not be determined.Information from this incident has been included in our product complaint and mdr trend reporting systems.Trend information is used to identify the need for additional investigations.
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