| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00707-1 |
| Product Name/Description |
Alaris System PC Unit (PCU) model 8015, software version 9.12
Multiple serial numbers affected
ARTG Number: 146664 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
12/07/2013 |
| Responsible Entity |
|
| Reason/Issue |
In the affected devices, the keyboard processor is operating at an incorrect voltage. The correct voltage should be at 1.8 volts however the affected units are at 1.4 volts. Due to this issue the Alaris System PCU software v9.12 while in operation could potentially experience a loss of communication between the PCU main Processor and Keyboard Processor. The Alaris System PCU will display either a SYSTEM ERROR (error codes 111.2000 or 111.2002) or CHANNEL DISCONNECTED error message. Along with the PCU display the Alaris System PCU also produces an audible alarm and the attached modules will display a scrolling "COMMUNICATION ERROR" message. During the communication error, the pump will alarm both visually and audibly. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Customers are asked to weigh the risk/benefit to patients before continuing to use the affected PCU, version 9.12. Either discontinue use of affected PC units until remediated or continue use on patients by implementing work around instruction identified in the customer letter.
CareFusion Technical Service will provide a software update to correct the voltage on the keyboard processor for those affected Alaris System PC units. |
| Contact Information |
02 9624 9013 - Carefusion Regulatory Affairs |