May 2018

HeartMate 3™ Left Ventricular Assist System: Class I Recall - Due to Potential Malfunction that may Lead to Graft Occlusion

Ampicillin and Sulbactam for Injection USP, 3 g Single-Dose Vials by AuroMedics Pharma: Recall - Presence of Red Particulate Matter

Piperacillin and Tazobactam for Injection, USP 3.375 g Vials by AuroMedics Pharma: Recall - Vials Contain Particulate Matter

Outbreak Alert Update: Potential Life-Threatening Vitamin K-Dependent Antagonist Coagulopathy Associated With Synthetic Cannabinoids Use

This COCA Clinical Action updates the message sent on April 5, 2018: https://content.govdelivery.com/accounts/USCDC/bulletins/1e6dac3

Since the index case was identified on March 8, 2018 in Illinois, at least 160 people have presented to Healthcare facilities with serious unexplained bleeding. The preponderant number of patient presentations were in Illinois with other cases being reported from Florida, Indiana, Kentucky, Maryland, Missouri, Pennsylvania, Virginia, and Wisconsin. Laboratory investigation confirms brodifacoum exposure in at least 60 patients. There are at least 3 fatalities. At least 7 synthetic cannabinoids product samples related to this outbreak have tested positive for brodifacoum. At least one synthetic cannabinoids product has tested positive for both synthetic cannabinoid AB-FUBINACA and brodifacoum.

Liberty Select Cycler Recall

On 01/25/2018, Fresenius Medical Care Renal Therapies Group, LLC 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.