Regulatory: Device Recalls

Pacific Medical Group Inc. - Alaris Pump, installed by Pacific Medical Group (DBA Avante Health Solutions) - Class 1 Recall
Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions)

Heartware, Inc. - HeartWare HVAD System - Class 1 Recall
Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these system components: HVAD Sterile Implant Kit, Model Numbers: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, MCS1705PU HVAD Controller Kit, Model Numbers: 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP,...

Heartware, Inc. - Medtronic HVAD Battery - Class 1 Recall
Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE

Heartware, Inc. - Medtronic HVAD Packaged Monitor - Class 1 Recall
Medtronic HVAD Packaged Monitor, Model Numbers: 1500, 1500AU, 1500DE, 1510US, 1511AR, 1511AU, 1511BR, 1511CA, 1511CH, 1511DE, 1511GB, 1511IL, 1511IN, 1511IT, 1511JP, 1511MY, 1520CLIN-AU, 1520CLIN-DE, 1520CLIN-GB, 1520JP, 1520US, 1521AU, 1521BR, 1521CA, 1521CH, 1521DE, 1521GB, 1521IL, 1521IN, 1521IT, 1521JP, 1521KR,...

Heartware, Inc. - Medtronic HVAD Monitor Data Cable - Class 1 Recall
Medtronic HVAD Monitor Data Cable, Product Number: 1575

Heartware, Inc. - Medtronic HVAD Controller AC Adapter - Class 1 Recall
Power Supply: 1. Medtronic HVAD Controller AC Adapter, Product Numbers: 1425AU, 1425CA, 1425DE, 1425GB, 1425IL, 1425IT, 1425US, 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, 1430US 2. Medtronic HVAD Controller DC Adapter, Product Number: 1440

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ECMO Research

Application of extracorporeal membrane oxygenation to treatment of serious tracheal stenosis caused by relapsing polychondritis: a case report and literature review
Relapsing polychondritis (RP) is a multisystemic rheumatic disease characterized by widespread and potentially destructive inflammatory lesions of the cartilage. The rarity of this disease and the lack of pathological diagnostic laboratory tests can occasionally lead to delayed diagnosis. We herein describe a...

Safety of Interhospital ECMO Transport by Low-Volume ECMO Transport Centers
We present our 20 years of experience as a low-volume extracorporeal membrane oxygenation (ECMO) transport center from the Southeast United States. This is a retrospective chart review of all ECMO transported patients between 1998 and 2017. Of 26 patients who were ECMO transported, median age was 15.5 days, 14...

Approach to Sedation and Analgesia in COVID-19 Patients on Venovenous Extracorporeal Membrane Oxygenation
CONCLUSIONS: Historically, sedation and analgesia management in patients requiring ECMO support have posed a challenge for bedside clinicians given the unique physiological and pharmacokinetic changes in this patient population. A multimodal strategy to managing analgesia and sedation should be used, and the use...

Efficacy, Safety, and Strategies for Recombinant-Activated Factor VII in Cardiac Surgical Bleeding: A Narrative Review
As perioperative bleeding continues to be a major source of morbidity and mortality in cardiac surgery, the search continues for an ideal hemostatic agent for use in this patient population. Transfusion of blood products has been associated both with increased costs and risks, such as infection, prolonged mechanical...

Comparison of Bivalirudin Versus Heparin for Maintenance Systemic Anticoagulation During Adult and Pediatric Extracorporeal Membrane Oxygenation
CONCLUSIONS: When compared with heparin-based systemic anticoagulation, bivalirudin demonstrated feasibility and safety as established by the absence of increases in identifiable adverse outcomes while manifesting substantial improvements in hospital mortality in adult patients. Further studies are necessary to...

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