Safety warnings

Latest safety warnings

• 24 Jul 2008| MDA/2008/056 - Laboratory analysers and their associated assays - ADVIA Centaur and ADVIA Centaur XP Immunoassay Systems, manufactured by Siemens Healthcare Diagnostics, serial numbers 078-A001-XX and XP 078-A010-XX

  This Medical Device Alert highlights an issue with the ADVIA Centaur and ADVIA Centaur XP systems which may fail to alert the user when the wash 1 bottle is nearly empty. This may lead to incorrect test results in high risk biomarkers.

• 24 Jul 2008| MDA/2008/055 - Homecare, intensive care and transport ventilators - Pulmonetic Systems (Cardinal Health) LTV1000, LTV950, LTV900, service agents Carina VT

  This Medical Device Alert has been issued due to affected ventilators that may fail in use without appropriate alarms.

• 23 Jul 2008| Class 4 Drug Alert (Caution in Use): Baxter Healthcare Ltd - Accusol 35 Solution, Accusol 35 Potassium 2 mmol/l and Accusol 35 Potassium 4 mmol/l - EL(08)A/9

  We have been informed that some batches of Accusol 35 Solution, Accusol 35 Potassium 2 mmol/l and Accusol 35 Potassium 4 mmol/l have formed visible white precipitate during haemofiltration in Continuous Renal Replacement Therapy (CRRT).

• 22 Jul 2008| MDA/2008/054 - Smiths Medical Portex™ Blue Line Ultra tracheostomy kits, lot no 499265

  This Medical Device Alert highlights that mislabelling of the device may result in the use of a fenestrated suction tube, reducing both suction and ventilation.

• 22 Jul 2008| MDA/2008/053 - Unomedical OP suction tubing lot 182281 only

  This Medical Device Alert has been issued after the manufacturer identified a manufacturing error with the potential for the tubing to collapse whilst in use, preventing suction.

• 21 Jul 2008| MDA/2008/052 - Puma and Beatle battery powered wheelchairs manufactured by Movingpeople.net or Handicare

  This Medical Device Alert has been issued due to some variants of the Puma and Beatle being too heavy for the standard four point webbing tie-down system available for use in a vehicle.

• 21 Jul 2008| MDA/2008/051 - Kimal safety fistula needle (all product codes and lots)

  This Medical Device Alert has been issued after Kimal identified the potential for the unintentional retraction of the cannula into the protection sheath.

• 08 Jul 2008| MDA/2008/050 - Harrier Heavy Duty (HD) battery powered wheelchair manufactured by Invacare

  This Medical Device Alert has been issued as these wheelchairs have been supplied without battery transportation straps, with the potential for the battery to detach from the frame in the event of a vehicle impact

• 02 Jul 2008| MDA/2008/049 - Smiths Medical Graseby Omnifuse and Omnifuse PCA syringe

  This Medical Device Alert has been issued due to a possibility of patients being given an additional/unnecessary infusion when syringes are changed or infusions restarted when using DrugPro software.
  

• 02 Jul 2008| MDA/2008/048 - BabyCare crib trolleys with drop-shelves, manufactured by Huntleigh Healthcare and Hoskins Medical Equipment

  This Medical Device Alert has been issued because the drop-shelves fitted to these crib trolleys may collapse under the weight of a baby bath and should not be used for this purpose.