—#115366

Product

Plum A+ Hyperbaric Infusion Pump; List Number 11005; Labeled in part: PLUM A+ HYPERBARIC; 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

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K081412
Affected lot / code info: List No. 11005; Serial Numbers: 16792201, 16792202, 16792205, 16792206, 16792208, 16792209, 16792210, 16792211, 16792213, 16792216, 16792217, 16792219, 16792220, 16792222, 16792223, 16792224, 16792225, 16792226, 16792227, 16792228, 16792230, 16792232, 16792233, 16792234, 16792235, 16792236, 16792238, 16792239, 16792240, 16792241, 16792242, 16792244, 16792245, 16792246, 16792248, 16792249, 16792250, 16792251, 16792252, 16792253, 16792254, 16792255, 16792256, 16792257, 16792258, 16792259, 16792260, 16792261, 16792263, 16792264, 16792265, 16792266, 16792268, 16792269, 16792271, 16792272, 16792273, 18807402, 18807405, 18807406, 18807407, 18807408, 18807409, 18807410, 18807413, 18807414, 18807417, 18807418, 18807420, 18807421, 18807423, 18807427, 18807428, 18807429, 18807430, 18807431, 18807432, 18807433, 18807434, 18807439, 18807443, 18807444, 18807446, 18807449, 18807452, 18807453, 18807455, 18807456, 18807459, 18807463, 18807466, 18807472, 18807474, 18807478, 18807484, 18807485, 18807486, 18807490, 18807491, 18807494, 18807496, 18807499, 18807500, 18807501, 18807506, 18807509, 18807510, 18807511, 18807513, 18807514, 18807518, 18807523, 18807524, 18807529, 18807535, 18807536, 18807539, 18807540, 18807541, 18807542, 18807543, 18807545, 18807546, 18807556, 18807557, 18807568, 18807574, 18807575, 18807576, 18807578, 18807581, 18807584, 18807585, 18807586, 18807588, 18807589, 18807590, 18807591, 18807596, 18807597, 18807598, 18807599, 18807600, 18807601, 18807602, 18807604, 18807605, 18807607, 18807608, 18807609, 18807610, 18807611, 18807612, 18807613, 18807614, 18807617, 18807618, 18807619, 18807620, 18807623, 18807625, 18807626, 18807627, 18807628, 18807630, 18807631, 18807632, 18807633, 18807634, 18807636, 18807637, 18807639, 18807640, 18807695, 18807696, 18807697, 18807698, 18807699, 18807700

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Hospira Inc.
Address: 275 N Field Dr, Lake Forest, Illinois 60045-2579

Distribution

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.

Timeline

Recall initiated: 2012-02-05
Posted by FDA: 2013-11-14
Terminated: 2016-11-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #115366. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.