Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
Recall
- Recall Number
- Z-1673-2014
- Event Number
- 68293
- Firm
- Bayer Corp
- FEI Number
- 3010933360
- Product Code
- FRN
- Status
- Terminated
- Root Cause
- Component design/selection
- Initiated
- April 3, 2014
- Posted
- May 30, 2014
- Terminated
- April 16, 2015
- Address
- 100 Global View Dr, Warrendale, PA, 15086-7601
Description
Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
There is a potential safety risk associated with potentially damaged locking pins within the bracket of non-wireless versions of Continuum systems shipped prior to March 2008.
Bayer sent an Urgent Medical Device Recall and Removal Letters dated April 3, 2014, and April 30, 2014, were sent to direct accounts to notify them of the bracket issue and to provide additional instructions for testing and/or returning the brackets. As a critical medical needs site currently using Continuum with a recalled bracket you have two options: 1. Immediately return your Continuum(s) for refund. 2. Take actions to ensure continued safe use of your system associated with the bracket recall. You will still be eligible for a refund when you return the system no later than June 30, 2015. When you are ready to return your Continuum(s), please refer to: Enclosure 2: Disassembly Instructions. Enclosure 3: Continuum Return Form. We sincerely regret the inconvenience and impact of the recalls and subsequent removal of Continuum from the market. Should you have questions regarding the pro-rated refund program, please call 877-229-3767.
Worldwide Distribution - USA (nationwide) including the countries of Australia, Brazil, Belgium, Canada, Germany, Singapore, South Africa, Poland, Mexico and UAE.
1347