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June 2018

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  • Outbreak of Hepatitis A Virus (HAV) Infections among Persons Who Use Drugs and Persons Experiencing Homelessness

    Tuesday, June 12, 2018

    The Centers for Disease Control and Prevention (CDC) and state health departments are investigating hepatitis A outbreaks in multiple states among persons reporting drug use and/or homelessness and their contacts. This Health Alert Network (HAN) Advisory alerts public health departments, healthcare facilities, and programs providing services to affected populations about these outbreaks of hepatitis A infections and provides guidance to assist in identifying and preventing new infections.

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  • Class 2 Device Recall Liberty Select Cycler

    Friday, June 8, 2018

    Fresenius Technical Service  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.

    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.

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  • Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride Injection

    Friday, June 8, 2018

    Hospira, Inc., a Pfizer company, is voluntarily recalling lots 72680LL and 76510LL of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system (NDC 0409-1782-69), to the hospital/institution level due to the potential presence of embedded and loose particulate matter on the syringe plunger.

    In the event that impacted product is administered to a patient, the patient has a low likelihood of experiencing adverse events ranging from local irritation, allergic reactions, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, pulmonary dysfunction, pulmonary infarction, and toxicity. The risk is reduced by the possibility of detection, as the labeling contains a clear statement directing visual inspection of the product for particulate matter and discoloration prior to administration. To date, Hospira, Inc. has not received reports of any adverse events associated with this issue for these lots.

    Naloxone Hydrochloride, an opioid antagonist, is indicated for the complete or partial reversal of opioid depression. It is also indicated for the diagnosis of known or suspected opioid overdosage, and as an adjunctive agent for the management of septic shock. It is available as a sterile solution for intravenous (IV), intramuscular (IM), and subcutaneous (SC) administration. Naloxone is supplied in a Carpuject single-use cartridge with a 1 mL fill for use with the Carpuject syringe system.
    The NDC, Lot Number, Expiration Date, Strength and Configuration details for Naloxone Hydrochloride Carpuject Injection is indicated below. Product lots were distributed nationwide to wholesalers/distributors/hospitals in the United States, Puerto Rico, and Guam from February 2017 to February 2018.

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  • Update – CDC Recommendations for Managing and Reporting Shigella Infections with Possible Reduced Susceptibility to Ciprofloxacin

    Friday, June 8, 2018

    This Health Alert Network (HAN) Update provides current recommendations on management and reporting of Shigella infections that have been treated with ciprofloxacin or azithromycin and resulted in possible clinical treatment failure. This is a follow-up to HAN 401: CDC Recommendations for Diagnosing and Managing Shigella Strains with Possible Reduced Susceptibility to Ciprofloxacin.

    The Centers for Disease Control and Prevention (CDC) continues to identify an increasing number of Shigella isolates that test within the susceptible range for the fluoroquinolone antibiotic ciprofloxacin (minimum inhibitory concentration [MIC] values of 0.12-1 μg/mL), but harbor one or more resistance mechanisms. CDC remains concerned about potential clinical failures with fluoroquinolone treatment.

    Clinicians should carefully monitor patients with Shigella infections who require fluoroquinolone treatment and report any possible treatment failures. If treatment failure is suspected, clinicians should submit a stool specimen for antimicrobial susceptibility testing, and consider consulting an infectious disease specialist to identify best treatment options.

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  • HeartWare HVAD System by Medtronic: Class I Recall - Due to Unintended Intermittent Electrical Disconnection between the Power Source and the Controller

    Tuesday, June 5, 2018

    Medtronic is recalling the HeartWare HVAD because of the possibility for an interruption to occur in the electrical connection between the system’s power source (battery, AC adapter, or DC adapter) and the HVAD controller. This interruption to the electrical connection, which occurs when the power source is still physically connected, is caused by oxidation on the connecting surfaces between the power source connector and the controller’s power source socket. Interruptions to the electrical connection could cause unintended intermittent electrical disconnection, which could result in a pump stop. A pump stop could cause patient harm such as exacerbation of heart failure symptoms, or symptoms such as mild weakness, dizziness, anxiety, nausea, loss of consciousness, or death.

    A full list of affected devices is available in the FDA recalls database.

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