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Recall Observatory FDA recall evidence

Device product

Plum A+ Infusion Pump; List Number: 11973; 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

Z-0205-2014

February 05, 2012

Class II

Product summary

Firm
Hospira Inc.
Event
Event 64091
Status
Terminated
Classification
Class II
Quantity
List No. 11973: 71 units
Official record key
device-enforcement:Z-0205-2014

Official wording

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

Code information: List No. 11973; Serial Numbers: 12570148 , 12570150 , 12570154 , 12570163 , 12570170 , 12570177 , 12570204 , 12570211 , 12570212 , 12570255 , 12570270 , 12570319 , 12570359 , 12570385 , 12570413 , 12570425 , 12570455 , 12570487 , 12570662 , 12570695 , 12570854 , 12570915 , 12571080 , 12571243 , 12571437 , 12571631 , 12571692 , 12571776 , 12571826 , 12571835 , 12571837 , 12571842 , 12571877 , 12571880 , 12571886 , 12572317 , 12572369 , 12572586 , 12572909 , 12573547 , 12573567 , 12573837 , 12573990 , 12574424 , 12574501 , 12574524 , 12574556 , 12574599 , 12574619 , 12574731 , 12574749 , 12574853 , 12574858 , 12574860 , 12574865 , 12574961 , 12575626 , 12575698 , 12575886 , 12576125 , 12576443 , 12576485 , 12576518 , 12576593 , 12576609 , 12576710 , 12576722 , 12577271 , 12577685 , 12578856 , 12579183

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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