| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-00850-1 |
| Product Name/Description |
Pressure Plates used in Level 1 Fast Fluid Flow Fluid Warmers
Level 1 Fluid Warming System
Model numbers: H-1000, H-1025, H-1200
Level 1 H-2 Pressure Chamber
Model number: 7204012
Serial Numbers / Lot Numbers: 44000448 to 44006780
ARTG 241980
(Smiths Medical Australasia Pty Ltd - Convection blood/fluid warmer, high-flow) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
11/07/2022 |
| Responsible Entity |
|
| Reason/Issue |
Smiths Medical implemented a design change to widen the hinge assembly on the Level 1 H-2 Pressure Chambers used with the Level 1 Fast Flow Fluid Warmers (Models H-1025 or H-1200) or added to the H-1000 model. Smiths Medical has become aware that Level 1 H-2 Pressure Chambers with the wider hinge assembly can potentially impact the amount of pressure exerted onto the IV fluid bag while contained within the pressure chamber. This may result in decreased flow rate, stopped flow or residual fluid left within the IV bag.
Decreased flow rate, stopped flow or residual fluid left within the IV bag could potentially result in under-delivery or delay of therapy leading to potential inadvertent hypothermia, hypovolemia, and/or hypotension. To date, Smiths Medical has received three (3) reports of deaths and sixty-four (64) reports of serious injuries potentially related to this issue. |
| Recall Action |
Product Defect Alert |
| Recall Action Instructions |
Smiths Medical are advising customers to identify if stock is impacted per the instructions in the Customer Letter (supplied to impacted users by the sponsor).
If the device is affected with the wider hinge assembly, the hinge should be replaced. Smiths Medical will contact users when the replacement kit is available through the email id PressureChamberFieldCorrection@icumed.com. Until the replacement kit is available, please take the steps within the Customer Letter. |
| Contact Information |
regulatory.affairs@smiths-medical.com - Smiths Medical |