Events

Recall of Device Recall LifeCare PCA Plus II

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hospira Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    68318
  • Event Risk Class
    Class 2
  • Event Number
    Z-2139-2016
  • Event Initiated Date
    2013-03-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-11-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127328
  • Notes / Alerts
    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.
  • Extra notes in the data
    Pump, infusion - Product Code FRN
  • Reason
    Hospira has received reports of pca pumps not detecting distal occlusions, one of which resulted in a serious injury. the issue is caused by normal wear and tear on the half nut (the component/nut that travels up and down the lead screw) which prevents it from properly detecting the pressure build-up associated with a distal occlusion.
  • Action
    Hospira sent an IMPORTANT DEVICE INFORMATION letter dated March 8, 2014 to all affected customers.. The letter advised customers to: 1) Perform the Performance Verification Test (PVT) Occlusion Test as defined in the PCA Technical Service Manual (TSM); 2) If the device does not pass the test, remove it from clinical service and contact Hospira at 800-441-4100 (Monday - Friday, 8:00 AM - 5:00 PM CST) to report the issue; and 3) Perform the appropriate troubleshooting and repair activities defined by your facility, which may include returning the device to Hospira for further diagnosing and servicing. The letter advised the Hospira is in the process of establishing a useful life for the half nut and to determine when it will require replacement. A new Technical Service Manual will be issued in late 2014 that adds a requirement for annual PVT Occlusion testing. The System Operating Manual will include new instructions to reduce the excessive wear on the half nut resulting from incorrectly using the vial information. Customers who further distributed the devices are requested to notify their customers of the recall and ask them to call Stericycle at 888-965-5801 (Monday - Friday, 8:00 AM - 5:00 PM EST) to receive a reply form. Questions about this recall should be direct to Hospira at 800-441-4100 (Monday - Friday, 8:00 AM - 5:00 PM CST).

Device

Device Recall LifeCare PCA Plus II
  • Model / Serial
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY) + District of Columbia + Puerto Rico + Virgin Islands; *** FOREIGN:
  • Product Description
    The LifeCare PCA Plus II infusion pump system is designed for safe, effective, analgesic delivery to patients through the intravenous or epidural routes in a wide range of clinical settings, including ICU, CCU, SICU, trauma units, bone marrow transplant centers, burn units, oncology centers, and medical/surgical nursing units.
  • Manufacturer
    Hospira Inc.

Manufacturer

Hospira Inc.
  • Manufacturer Address
    Hospira Inc., 275 N Field Dr, Lake Forest IL 60045-2579
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    USFDA