Events

Retiro De Equipo (Recall) de Device Recall Plum A Hyperbaric Infusion Pump

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Hospira Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    64091
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0203-2014
  • Fecha de inicio del evento
    2012-02-05
  • Fecha de publicación del evento
    2013-11-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-11-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115366
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Notas adicionales en la data
    Pump, infusion - Product Code FRN
  • Causa
    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.
  • Acción
    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.

Device

Device Recall Plum A Hyperbaric Infusion Pump
  • Modelo / Serial
    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
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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
  • Manufacturer
    Hospira Inc.

Manufacturer

Hospira Inc.
  • Dirección del fabricante
    Hospira Inc., 275 N Field Dr, Lake Forest IL 60045-2579
  • Empresa matriz del fabricante (2017)
    Pfizer
  • Source
    USFDA