The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The information provided by bd represents all of 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.The device was not returned.
|
The device was not returned for evaluation.The lot number is unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿1.The neonatal cap is only for use with an arctic sun ® temperature management system.See arctic sun ® temperature management system operators manual for detailed instructions on system use.2.To place the cap: ¿ place the cap following the diagram below.¿ place the cap on healthy clean skin only.Do not place the cap on skin that has signs of ulcerations, burns, hives or rash.¿ the cap surface must be contacting the skin for optimal energy transfer.3.Use the chin strap to ensure good contact between the cap and skin.¿ the patient¿s hair may act as an insulating layer and may reduce heat transfer efficiency.¿ the cap may be removed and reapplied by disconnecting and reconnecting the chin strap.4.Attach the cap line connectors to the fluid delivery line manifold.Begin circulating water through the cap using automatic mode (patient temperature control).5.Due to the small patient size and the potential for rapid patient temperature change: ¿ it is recommended use the following settings: water temperature high limit: =40°c (104°f) water temperature low limit: =10°c (50°f) control strategy: 2 ¿ it is recommended to use the patient temperature high and patient temperature low alert settings.6.If the cap fails to prime or a significant continuous air leak is observed in the cap return line, check connections, then if needed replace the leaking cap.7.Note: the neonatal cap has an internal integral shunt path that allows high flow rates required by the system.Therefore, the water flow indicated on the arctic sun ® temperature management system display does not represent the flow through the neonatal cap as only a portion of the flow travels through the neonatal cap.The flow can be seen through the clear pad connector, and should be monitored during use.8.An external shunt (ref 709-04) should not be used with the neonatal cap.9.When using a single neonatal cap with the arctic sun ® temperature management system, a flow rate status ¿low¿ will commonly occur.10.A small universal pad (ref 318-01) may be used if additional surface area is required to control patient temperature 11.When finished, purge the water from the cap, then remove cap from the patient and discard.Indications the arctic sun ® temperature management system is intended for monitoring and controlling patient temperature within a range of 32°c and 38.5°c (89.6°f and 101.3°f).Contraindications there are no known contraindications for the use of a thermoregulatory system.Warning do not place the neonatal cap over transdermal medication patches as warming can increase drug delivery, resulting in possible harm to the patient." section a through f - the information provided by bd represents all of 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.
|