Tag Archives: death
Cardinal Health

Various Presource Kits Containing a Pre-Assembled Anesthesia Circuit, by Cardinal Health, Recalled (Class I)

Anesthesiology, biomedical engineering, surgery personnel and risk managers are informed by the FDA that various presource kits containing pre-assembled anesthesia circuit, by Cardinal Health, are recalled because they main contain outer plastic packaging. Remnants of the plastic may cause serious adverse events including death. Background of Presource Kits Pre-Assembled Filter and Anesthesia Circuits, by Cardinal [...]

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HT70

HT70 and HT70 plus Ventilators by Newport Medical Instruments Recalled (Class I) due to Potential Malfunction

The FDA informs risk managers and nursing personnel that HT70 and HT70 plus Ventilators by Newport Medical Instruments are recalled because the device may go to internal backup battery sooner than expected and cause serious adverse events, including death. Background of HT70 and HT70 plus Ventilators The HT70 and HT70 Plus ventilator systems, by Newport [...]

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Samsca (Tolvaptan): Limited Duration and Usage Due To Possible Liver Injury

Samsca (Tolvaptan): Limited Duration and Usage Due To Possible Liver Injury

Pharmacy, health professionals and patients are informed that the FDA limits duration and usage of Samsca (Tolvaptan) due to possible liver injury that may lead to organ transplant or death. Background of Samsca (Tolvaptan) Samsca, by Otsuka America Pharmaceutical Inc., is a selective vasopressin V2-receptor antagonist used to treat clinically significant hypervolemic and euvolemic hyponatremia. [...]

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Stryker Instruments Neptune 1 Silver and Neptune 2 Ultra Waste Management System (Neptune 1 Silver and Neptune 2 Ultra): Reports of Serious Tissue Damage and Patient Death

Stryker Instruments Neptune 1 Silver and Neptune 2 Ultra Waste Management System (Neptune 1 Silver and Neptune 2 Ultra): Reports of Serious Tissue Damage and Patient Death

[Update] Additional death and injury reports to the FDA indicate that the high-flow, high-suction vacuum had been incorrectly applied and were associated with users of the device Neptune 1 Silver and Neptune 2 Ultra Waste Management System (Neptune 1 Silver and Neptune 2 Ultra) who had not been properly trained on how to use it. [...]

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