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Accessory Set Syringes (OriGen) – Qualification Concern (2023)

Accessory sets contain a syringes not yet qualified for the accessory's intended purpose; due to design changes to the syringe barrels and a polypropylene resin change that resulted in loss of gamma compatibility, for accessory set syringes that were gamma sterilized, which resulted in yellowed syringes.

Moderate

FDADec 19, 2023CA, DE, FL +8 more• OriGen Biomedical, Inc.

Medfusion 3500 Pump (Smiths Medical) – software alarm issue (2023)

Medfusion syringe pumps, with software versions before v6.0.0, may have the following issues:1. Delivery During Motor Not Running High Priority Alarm, 2. Infusion Restarted with Incorrect Parameters, 3. Screen Lock, 4. Interruption of Bolus or Loading Dose Delivery, 5. Pump Displays Incorrect Bolus/Loading Dose, 6. Loading/Bolus Dose Below the Minimum Recommended Rate, 7. Motor Rate Error, 8. Incorrect Recall Last Settings, 9. Corrupt Configuration, 10. Auto Lock, 11. Toolbox Configuration Loading Dose Time Values. Smiths Medical corrected all issues included in this notification in previous software updates and the corrections were carried forward into all subsequent software releases. Please ensure you have the most recent Medfusion software (v6.0.0) installed on your pumps.

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Accessory Set Syringes (OriGen) – Qualification Concern (2023)

Medfusion 3500 Pump (Smiths Medical) – software alarm issue (2023)

Medfusion Barrel Clamp (Smiths Medical) – pump component risk (2023)

Medfusion 4000 Pump (Smiths Medical) – software alarm issue (2023)

Syringe Pumps (Smiths Medical) – Barrel Clamp Guide Defect (2023)

Medfusion Syringe Pumps (Smiths Medical) – Barrel Clamp Guide Defect (2023)

iQ200 Urine Analyzers (Beckman Coulter) – Cannula Rust Risk (2023)

EndoVive Button Kit (Boston Scientific) – measurement error (2023)

REV 2 Flowcell (Beckman Coulter) – cannula rust problem (2023)

Intellis Programmer (Medtronic) – Session Establishment Issue (2023)

Acu-Loc Bone Plates (Acumed) – Distribution Clearance Issue (2023)

iQ Waste Well Adapter (Beckman Coulter) – Cannula Rust Risk (2023)

DxU Microscopy Analyzers (Beckman Coulter) – Cannula Rust Risk (2023)

TactiFlex Ablation Catheter (St. Jude) – System Recognition Issue (2023)

ACTU8 Forceps (Vortex Surgical) – Residue Contamination (2023)

PulseSpray Infusion System (Angiodynamics) – O-Ring Seal Defect (2023)

Operative LAP Kit (ROi CPS) – Component Recall Concern (2023)

ESG PK Cutting Forceps (Olympus) – Jaw Fracture Risk (2023)

ProxiDiagnost N90 (Philips) – Mixed Patient Images (2023)

ExcelsiusGPS Cannula (Globus) – Sterility Concern (2023)