HomeChoice/HomeChoice PRO Automated PD device 에 대한 현장 안전성 서한

Field Safety Notice

2016-01-15

Slovenia

AMPMDRS

Baxter healthcare corporation is updating the homechoice patient at-home guide addendum to include a discussion of the expected operating sounds associated with all homechoice and homechoice pro devices. the new labeling will address the following: the homechoice cycler utilizes an air (pneumatic) pump; some sounds related to the operation of this pump are expected as part of normal operation of the homechoice cycler. there will be sounds like humming, swishing, clicking, and venting (air being released) that are normal for the operation of the cycler. in certain portions of the therapy, the sound level is expected to increase which is also part of normal operation. if there is a significant change in the sound level or a new, previously unheard sound when using the homechoice cycler, please contact your doctor and/or nurse or baxter technical services. no auditory damage is expected from the level of noise generated by the homechoice, even in case of “noisy device”. the expected outcome for a noise issue is the notification to the clinician / technical service. if the noise is identified as undesirable, the homechoice will be swapped. in this case, an interruption in the therapy is unlikely as the unit continues to operate and remain capable of delivering therapy. for the patients who elect not to continue with therapy, a swap may result in a delay of therapy of less than 48 hours and mild overload and/or electrolyte imbalance may result. however, during homechoice training, patients are instructed to be able to perform manual therapy at home in case of device swap situation when the unit is not functional. in conclusion, while this issue may temporarily impact the patient’s quality of life (temporary discomfort), permanent injury is not expected. as worst case scenario, for the general population, missing therapies may result in mild fluid overloaded and/or electrolyte imbalance. this outcome is considered a minor severity or transient adverse health consequences. .