BD Expands Alaris 8100 Pump Module FDA Recall
BD has issued a recall notification and published Service Bulletin 621 on April 2019 to describe the models affected by the Pump Module Recall. The bulletin also details the cause of the problem and inspection criteria that should be used to identify pumps that fall under the recall. Below is a summary of the details around the recall and steps organizations should take if they have these pumps in practice.
1). Pump Identification
Pumps Not Affected include:
- Pumps that have “BD Alaris™ Pump” Branding
- Alaris pump modules manufactured after June 2017. Look for the Manufacture Date Symbol on the back of the pump.
- Alaris pump modules serviced with bezel assembly kit P/N 49000270.
- Alaris pump modules that were manufactured prior to April 2011 and have not been serviced with
customer-ordered bezel assembly kits P/N 10964559 or P/N 49000204. - Bezels that have No Seam + a Notch
Affected Pumps include:
- All other pumps Manufactured between April 2011 and June 2017 that have a Seam + No Notch in the bezel. The recall affects a total of 586,345 units in the US.
2). Inspect Affected Pumps For Damage
Identify Damaged Pumps and Take Out of Service. Inspect for:
- Damage to the bezel hinge.
- Damage to the bezel area near the air in-line sensor.
- Damage to the bezel underneath the Membrane Frame.
- Damage to the bezel inside the rear case.
- Damage to 3 bezel posts under the Logic Board.
- Damage to 3 bezel posts under the Motor Control Board.
This complex inspection method requires a technician to disassemble the unit down to the Logic and Motor Control Board levels using the appropriate tools.
3). Notify BD of Valox Bezel Replacements
Fill out the information on the bd recall notifications web page to obtain a custom form of all the affected devices at your facility and further instructions on how to submit your inspection results to BD.
4). Replace the Damaged Bezel Assembly and Reassembly Pump
Consult BD Service Bulletin 621 and the applicable Technical Service Manual for detailed bezel replacement and pump reassembly instructions.
5). Test All Affected Pumps
Retest all affected pumps; visibly damaged or not. Place all passing pumps back in service.
6). Complete the BD Customer Response Card
The Recall Customer Response Card serves as a confirmation that your organization has received the recall notification and took appropriate action.
7). Repeat Inspection during Yearly PM until bezel is replaced with a notched design Valox Bezel
Per Service Bulletin 621, “Until the bezels affected by this recall are replaced by BD or deemed unaffected in accordance with this inspection procedure, customers should inspect bezels during their annual preventive maintenance schedule. Any pumps with separated bezel posts should be removed from service.”
Additional Information
Per BD, there are 14 injuries reported to date within Priority 1 date range pumps which were manufactured between April 2011 and October 2014. BD is targeting replacement of all Priority 1 bezels within 12 months.
The bezels on Priority 2 date range pumps, manufactured between November 2014 and June 2017, are targeted to be replaced within 24 months.
All BD recall information for this issue including pictures and instructions, shown above, is sourced from the BD Recall page here.