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Ocean Water Seal Chest Drains (Atrium) – Setup Instructions (2023)

Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains

Moderate

FDASep 18, 2023Nationwide• Atrium Medical Corporation

Nova Stat Profile (Nova Biomedical) – Creatinine Results (2023)

Potential risk of reporting erroneous creatinine patient results associated with the initial start-up of a new BUN/Creatinine Sensor Cartridge. The potential risk is within the first 2-4 hours after cartridge installation that may not be identified by traditional Quality Control practices.

Moderate

FDASep 18, 2023Nationwide• Nova Biomedical Corporation

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Ocean Water Seal Chest Drains (Atrium) – Setup Instructions (2023)

Nova Stat Profile (Nova Biomedical) – Creatinine Results (2023)

BD Alaris Syringe Module (CareFusion) – Syringe Validation (2023)

Alaris PCA Module (CareFusion) – Syringe Validation (2023)

BD Alaris PCU (CareFusion) – Syringe Validation (2023)

Tornier Perform Glenoid Baseplate (Tornier) – Spacer Mismatch (2023)

EVIS EXERA III Video System (Olympus) – Power Supply Issue (2023)

Aptima CMV Quant Assay (Hologic) – Sample Error (2023)

Centricity PACS-IW (GE Healthcare) – Image Mixing (2023)

Centricity Universal Viewer (GE Healthcare) – Image Mixing (2023)

Centricity PACS-IW (GE Healthcare) – Image Mixing (2023)

Maquet Acrobat-i Stabilizer (Maquet) – Housing Mount Failure (2023)

Stryker Portal Entry Kit (Stryker) – Expired Product (2023)

Breg Walker (Breg) – Misaligned Wheels (2023)

Astral Ventilators (Unknown) – Battery Alarm Fault (2023)

Monoject Tuberculin Syringe (Cardinal Health) – Tip Compatibility (2023)

Thunderbeat Surgical Device (Olympus) – Button Malfunction (2023)

Cios Alpha C-arm (Siemens) – Software Update (2023)

BACTEC Culture Vials (Becton Dickinson) – Barcode Duplication (2023)

Cios Flow C-arm (Siemens) – Software Update (2023)