Events

Field Safety Notices about HomeChoice/HomeChoice PRO Automated PD device

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Baxter d.o.o..

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2016-01-15
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Extra notes in the data
    Our records indicate that 1 customer have received this product in Slovenia.
  • Reason
    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. .

Device

HomeChoice/HomeChoice PRO Automated PD device

Manufacturer

Baxter d.o.o.
  • Manufacturer Address
    BAXTER d.o.o. Železna cesta 18 1000 Ljubljana
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    AMPMDRS