Other Medical Devices

There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.

There have been cases of failure of the main board due to condensation water occurring in the gap between thermal insulation material on the underside of the main base dropping onto the main board The symptoms and errors differ depending on the position where the water drops adhere. To date there have been examples of reports of inter-board communication errors, HOME POSITION error or SLIP error of XYZ drive units. The failure could result in delay of patient sample testing.

There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.

Potential safety issue where a patient may be harmed while preparing for or during a scan.

The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort.

Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)

Potential safety issue where a patient may be harmed while preparing for or during a scan.

An out of specification component may result in the device exhibiting torque output higher than the design specification.

The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.

The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.

There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.

Potential safety issue where a patient may be harmed while preparing for or during a scan.

Steel cables in the Wall Stand for certain Proteus XR/a systems serviced by GE HealthCare have not been replaced at the intervals detailed in the Preventative Maintenance Action List.

Potential safety issue where a patient may be harmed while preparing for or during a scan.

Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.

Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.

Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.