Events

Recall of Device Recall Liberty Select Cycler

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Fresenius Medical Care Renal Therapies Group, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79625
  • Event Risk Class
    Class 2
  • Event Number
    Z-1365-2018
  • Event Initiated Date
    2018-01-24
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162848
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, peritoneal, automatic delivery - Product Code FKX
  • Reason
    The recalling firm identified a software issue related to the patient line check (plc) which may result in an increased risk of overfill (also known as increased intraperitoneal volume, iipv). overfill/iipv may result in serious injury or death.
  • Action
    On 01/25/2018, the recalling firm sent Urgent Medical Device Correction letters to affected Home Therapy Nurse Managers (HTNs). On 01/31/2018, the firm sent letters to affected patients. The letters informed customers of the recall and stated that patients who are considered "slow drainers" and experience M65 Scale warnings during one or more drain cycles are at increased risk. On 03/29/2018, the firm sent out a second Urgent Medical Correction Letter to HTNs, followed by a patient communication sent on 04/02/2018. In the second communication, the firm amended that slow drainers can develop Overfill/IIPV even without receiving M65 scale warning. Health care providers and patients using the device were advised to monitor drain rates and address the reasons for slow draining, such as constipation, fibrin deposition, peritonitis, and catheter malposition. Health care providers were advised to continue to review risk factors and symptoms of Overfill/IIPV with PD nursing staff and patients with extended drain times. The firm is not requesting the return of the recalled device at this time. For additional information and alternative treatment options, please contact the FMCRTG Medical Information Line at 1-855-616-2309. Hours of operation are 8:30AM-5:00PM (EST), Monday - Friday. Online requests may be submitted at any time at www.fmcna-medinfo.com.

Device

Device Recall Liberty Select Cycler

Manufacturer

Fresenius Medical Care Renal Therapies Group, LLC
  • Manufacturer Address
    Fresenius Medical Care Renal Therapies Group, LLC, 920 Winter St, Waltham MA 02451-1521
  • Manufacturer Parent Company (2017)
    Fresenius SE & Co KGaA
  • Source
    USFDA