BEUDAMED
    FDA Recall Terminated

    Plum A+ Infusion Pump; List Number: 11971; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care

    Recall: Z-0204-2014 · Initiated February 5, 2012

    Recall

    Recall Number
    Z-0204-2014
    Event Number
    64091
    Firm
    Hospira Inc.
    FEI Number
    3013319212
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 5, 2012
    Posted
    November 14, 2013
    Terminated
    November 14, 2016
    Address
    275 N Field Dr, Lake Forest, IL, 60045-2579

    Description

    Plum A+ Infusion Pump; List Number: 11971; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care

    Reason

    Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following error codes may be displayed during setup or infusion signifying possible calibration drift: E180/N180, E181/N181, E186/N186, E187/N187 or E346. Additionally, if the pressure sensor calibration has drifted, users may experience false distal occlusion alarms or distal occlusions that may not

    Action

    Hospira sent an URGENT DEVICE FIELD CORRECTION letter dated February 5, 2013 was sent to all direct accounts notifying them of the issue. For device users who experience these issues, Hospira recommends the following actions be taken: 1) Remove the pump from service and perform a Performance Verification Test (PVT) Distal Occlusion Test to determine if the distal pressure sensor is performing correctly. 2) If the device does not pass the PVT, it may indicate that the distal pressure sensor has drifted. Perform the appropraite troubleshooting and repair activities defined by the user's facility, whihc may include returning the device to Hospira for further diagnosis and servicing. The remediation for this issue is to perform a recalibration of the distal pressure sensor. Hospira also intends to release in 2013 a recommendation of a yearly test to determine if the distal pressure sensor's calibration has drifted. Customers who suspect that their device(s) may be affected by this issue are urged to contact Hospira at 1-800-441-4100 (Monday - Friday, 8:00 AM - 5:00 PM CST) to report the issue. Hospira will provide loaner devices if necessary. Customers are requested to complete and return the reply form included with the notification letter per the instructions on the reply form. For questions regarding this recall call 224-212-2000.

    Distribution

    Worldwide Distribution - USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and U.S. Virgin Islands; and countries of: Croatia, Dominican Republic, Turks and Caicos.

    Quantity

    List No. 11971: 10,669 units