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HOSPIRA INC

LIFECARE PCA · Anesthesiology

510(k): 3 Recall: 10 UDI: 0 MAUDE: 10 Class.: 59

510(k) Clearances (3)

LifeCare PCA Infusion System
2016-04-08

Substantially Equivalent

HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03
2004-12-06

Substantially Equivalent

LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
2004-10-18

Substantially Equivalent

Recalls (10)

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 med
2013-03-08

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.

LifeCare PCA infusion system with Hospira MedNet software allows clinicians to administer, or patients to self-administer analgesia, safely and effectively within clinician programmed limits and/or hospital-defined medication limits. The LifeCare PCA infusion system is used in a wide range of clinic
2013-03-08

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.

LifeCare PCA Infusion System with Hospira MedNet Software, PCA Serial List Number 20709 Allows for clinician administration or self-administration of analgesic medications.
2013-03-08

Screw rotation error occurring when the pump detects a mismatch between the number of steps given to the motor driving delivery and the number of steps the motor actually took. When this malfunction occurs, the pump will alarm and infusion stops.

LifeCare PCA 3, PCA Serial List Number 12384 Allows for clinician administration or self-administration of analgesic medications.
2013-03-08

Screw rotation error occurring when the pump detects a mismatch between the number of steps given to the motor driving delivery and the number of steps the motor actually took. When this malfunction occurs, the pump will alarm and infusion stops.

The LifeCare PCA infusion system with Hospira MedNet software allows clinicians, or patients, to (self) Administer analgesia within clinician programmed and/or hospital defined medication limits.
2013-02-27

The infusion pump has a clear plastic door that, due to its design, allows for excessive flexing. This in turn permits unauthorized access to the vial of medication.

AC Power Cords, shipped between 06/2005 and 05/2009. These cords were used in the following infusion pump models: Nutrimix, Q-Vue, Q2, Q2 Plus, Ox4, PCA, PCA II, PCA 3, Lifecare PCA, Lifecare 4100, Plum XL 3, Plum XL3M, Plum XL3D, Plum A+/ Plum A+3, and Gemstar Docking Station devices. AC cord m
2009-08-11

Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.

LifeCare PCA Plus II, list #01950-04-03, 01950-04-05, 01950-04-07, 01950-04-51; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.
2009-08-11

Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.

LifeCare PCA 3, list #s 12384-04-01, 12384-04-03, 12384-04-05, 12384-04-07, 12384-04-09, 12384-04-51; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.
2009-08-11

Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.

LifeCare PCA with Hospira Mednet, list numbers 20709-04-01, 20709-04-03, 20709-04-51, 20709-04-53, 20709-04-77; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.
2009-08-11

Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.

Hospira LifeCare PCA Label Utility, Version 1.0 CD. The installation/user guide is entitled "LifeCare PCA Barcode Label Utility Program." This software program is designed to allow entry of each drug concentration into a formulation library on a pharmacy computer for standardized printing of barc
2008-01-03

Incorrect dosage labels created: Customers have experienced independent changes in drug concentration (mg/mL to mcg/mL and vice versa) and expiration dates, and the addition of trailing zeros to the barcodes.

MAUDE Adverse Events (10)

Malfunction
20080401
Malfunction
20080401
Death
20080303
Injury
20080228
Injury
20080206
Injury
20080117
Injury
20080107
Malfunction
20080101
Injury
20071222
Death
20071218

FDA Classification (59)

Ventilator, Continuous, Minimal Ventilatory Support, Home Use

Anesthesiology

Humidifier, Respiratory Gas, (Direct Patient Interface)

Anesthesiology

Anesthesia Conduction Kit

Anesthesiology

Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia

Anesthesiology

High Flow/High Velocity Humidified Oxygen Delivery Device

Anesthesiology

Monitor, Carbon-Dioxide, Cutaneous

Anesthesiology

Plethysmograph, Pressure

Anesthesiology

Caudal Anesthesia Kit

Anesthesiology

Regulator, Pressure, Gas Cylinder

Anesthesiology

Bag, Reservoir

Anesthesiology

Brush, Cleaning, Tracheal Tube

Anesthesiology

Analyzer, Nitrogen Dioxide

Anesthesiology

Algesimeter, Powered

Anesthesiology

Ventilatory Effort Recorder

Anesthesiology

Adjunctive Pain Measurement Device For Anesthesiology

Anesthesiology

Rhinoanemometer (Measurement Of Nasal Decongestion)

Anesthesiology

Cabinet, Table And Tray, Anesthesia

Anesthesiology

Spreader, Cuff

Anesthesiology

Stethoscope, Esophageal

Anesthesiology

Oral Airway Assist

Anesthesiology

Spirometer, Diagnostic

Anesthesiology

Device, Positive Pressure Breathing, Intermittent

Anesthesiology

Sparse Sample Pk Profile And Dosing Software

Anesthesiology

Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)

Anesthesiology

Airway, Oropharyngeal, Anesthesiology

Anesthesiology

Airway, Nasopharyngeal

Anesthesiology

Device Indicating An Exhalation Event

Anesthesiology

Spacer, Direct Patient Interface

Anesthesiology

Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

Anesthesiology

Apparatus, Gas-Scavenging

Anesthesiology

Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase

Anesthesiology

Circulator, Breathing-Circuit

Anesthesiology

Percussor, Powered-Electric

Anesthesiology

Laryngoscope, Rigid

Anesthesiology

Blood Specimen Collection Kit (Excludes Hiv Testing)

Anesthesiology

Catheter, Nasal, Oxygen

Anesthesiology

Stimulator, Nerve, Ac-Powered

Anesthesiology

Valve, Switching (Ploss)

Anesthesiology

Stool, Anesthesia

Anesthesiology

Analyzer, Gas, Nitrogen, Gaseous-Phase

Anesthesiology

Stimulator, Nerve, Battery-Powered

Anesthesiology

Mask, Oxygen, Non-Rebreathing

Anesthesiology

Vaporizer, Anesthesia, Non-Heated

Anesthesiology

Analyzer, Gas, Neon, Gaseous-Phase

Anesthesiology

Cardiopulmonary Resuscitation Aid Kit

Anesthesiology

Catheters, Suction, Tracheobronchial

Anesthesiology

Spinal Anesthesia Kit

Anesthesiology

Analyzer, Nitrogen Dioxide, Exempt

Anesthesiology

Calibrator, Pressure, Gas

Anesthesiology

Needle, Conduction, Anesthetic (W/Wo Introducer)

Anesthesiology

Protector, Dental

Anesthesiology

Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)

Anesthesiology

Valve, Non-Rebreathing

Anesthesiology

Monitor, Breathing Frequency

Anesthesiology

Hood, Oxygen, Infant

Anesthesiology

Medevac Use Oxygen Generator

Anesthesiology

Support, Patient Position

Anesthesiology

Strap, Head, Gas Mask

Anesthesiology

Tube, Tracheostomy (W/Wo Connector)

Anesthesiology