Baxter Colleague Single Monochrome

Typical Location

Where this class of equipment is typically deployed - general reference, not this unit's own placement record.

• Patient care floors
• ICU
• OR
• Oncology / infusion centers
• Home health (portable pumps)

Documents & Manuals

No documents available for this device yet.

Safety & Recalls

Synced live from the FDA openFDA API.

• RECALL

  There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.

• RECALL

  Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be unaware of a possible decrease in oxygen levels (oxygen desaturation), or potential lung tissue injury from overexpansion (barotrauma) when the Volara device is used in the home care environment. This correction is providing the home caregiver specific instructions for use.

• RECALL

  Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of thermal skin injuries when using the iLED 7 surgical light system products listed below. Specific VidiaPort and Trulight product codes are also impacted as they are equipped with iLED 7 light-heads

• RECALL

  Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.

• RECALL

  There is a potential leak between the venous patient connector and patient's hemodialysis access.

• RECALL

  complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.

• RECALL

  There were customer reports of separation between the tubing and Male Luer Lock Adaptor.

• RECALL

  Potential disconnection of tubing set.

• RECALL

  Potential presence of particulate matter on the blood side of the dialyzer

• RECALL

  Instructions for use booklet may puncture the outer Tyvek lid.

• RECALL

  Baxter Corporation is conducting a field action for the ABACUS SE and ME models due to the possibility that the compounder will load the incorrect formula upon scanning the bag label when two or more different formula files have been created with the same order number.

• RECALL

  Potential for device malfunction resulting in flow when the device should not be flowing

• RECALL

  1. ABACUS v3.1 may calculate quantities of electrolytes that are double the expected values during the creation of TPN orders. 2. ABACUS v3.1 may automatically add additional sterile water to a formula equal to the volume of a premix resulting in an over dilution. 3. All software versions of ABACUS software display the calcium phosphate curve points for Premasol incorrectly. 4. All software v

• RECALL

  Baxter Healthcare Corporation is issuing a voluntary correction for ABACUS Total parenteral Nutrition (TPN) Calculation Software versions 2.0 through 3.0 due to the possibility that a patient could receive another patient's TPN order as a result of data corruption.

• RECALL

  Incomplete foil seal on one lot of sterile product.

• RECALL

  Due to an increase in complaints for leaks at the distal male Luer and Luer cap. Baxter implemented enhancements to the blue winged cap to improve the seal between the cap and the Luer.

• RECALL

  Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.

• RECALL

  The Tina System was released to the customer with OOS values for the Pressure Displays Accuracy and Leakage Rate Test.

• RECALL

  Baxter's Service Center tested and returned to the user the Colleague infusion pump that did not meet PSIG (Pounds-force per Square Inch) specifications

• RECALL

  The Colleague infusion pump may not have met certain Air in Line (AIL) specifications after testing by the Baxter Global Technical Service Center. This issue could potentially cause a delay in initiation of therapy.

• RECALL

  A review of Baxter service records indicates that the Baxter Colleague CX Infusion Pump has not met certain voltage specifications. This issue could potentially cause a delay in initiation of therapy.

• RECALL

  While replacing a defective pump head mechanism and performing calibration, Baxter's Service center may have failed to apply GLYPTOL (a red insulating varnish) on a potentiometer that helps maintain pump accuracy for detecting an air bolus.

• RECALL

  The Air In Line (AIL) test was not properly performed by the service technician at the Service Center.

• RECALL

  The Hi-Pot safety testing may not have been conducted on the affected pumps during service, prior to being returned to the end user.

• RECALL

  Some of the Single Day Infusor System 2 mL/h have a foil over-pouch that was incorrectly labeled as the Half Day Infusor System 5 mL/h, product code 2C1073KJP, lot 10H054.

• RECALL

  While the infusion pump was being serviced at the Baxter Service Center, it was inadvertently routed to the packaging area before the final inspection.

• RECALL

  The Air In Line (AIL) test was not properly performed by the service technician at the Service Center.

• RECALL

  The FDA sent a letter to Baxter on April 30, 2010, ordering the company to recall and destroy all models of its Colleague Volumetric Infusion Pumps currently in use in the United States. FDA determined that this action is necessary, as Baxter has failed to adequately correct, within a reasonable timeframe, the deficiencies in the Colleague pumps still in use. This recall is a consolidation of al

• RECALL

  Baxter's Service Center did not perform the ground impedance and leakage current test which verify if any power overflow occurs and that it is properly discharged through the device electrical system.

• RECALL

  Some of the 1550 Hemodialysis Instruments may have replacement circuit boards with incorrect versions of software.

• RECALL

  There was no documentation to show the required tests were performed following the replacement of the battery and battery harness.

• RECALL

  Baxter has identified failure codes that lead to an interruption of therapy, hazards associated with improper cleaning, and damaged battery messages for the Colleague Infusion Pumps.

• RECALL

  Leaking: leaks at the tubing flow restrictor connection to either the coupler or the male luer during filling.

• RECALL

  Some of the pumps were upgraded by one service technician who failed to replace prisms and batteries as required in the upgrade.

• RECALL

  A software anomaly is causing newly upgraded Colleague Triple Channel Infusion Pumps to alarm, display an error code (16:310:867:0002) and stop the infusion. This occurs during user programming with all three channels simultaneously infusing fluids. In reported cases, the pump stopped infusing and both an audible and a visual alarm notification were activated.

• RECALL

  Baxter has identified the potential for a corruption of the memory chip in the pump to occur due to linear accelerator radiation exposure. If corruption occurs, it could result in an interruption of therapy with an audible and visual alarm notification to the user.

• RECALL

  Interruption of therapy due to battery undercharging, the generation of air-in-line alarms due to IV administration set tugging, and gearbox wear; and underinfusion due to misalignment of the pump head components.

• RECALL

  A hardware problem can cause internal communications errors which halt therapies, generate alarms and communication failure codes.

• RECALL

  Operator's Manuals addenda are being issued to provide correct information concerning the correct syringe size to use for heparin infusion, the use of chemical disinfectants in the System 1000, TMP Advise, and Bicarbonate Value calculations.

• RECALL

  The pumps may experience inadvertent power off, external communications port failures and electronic pump failure codes 402, 403, 533, 535, 599, 810:04 and 810:11.

• RECALL

  Swelling of the sealed lead-acid batteries in the infusion pump can cause internal pump damage, and excessive battery discharge can damage the batteries if the pump is left on battery power for an extended period of time after teh Battery Depleted alarm occurs.

• RECALL

  A software anomaly causes a failure alarm code 12:303 which audibly alarms and stops the function of all channels in use. This causes an interruption in therapy, which may result in a risk to the patient.

• RECALL

  Ink deterioration of the letters, numbers and symbols of the programming and pump channel keypads, which may impact the legibility of the keys over time.

• RECALL

  These devices have the potential to overheat in the absence of a Ground Fault Circuit Interrupter (GFCI). This heater system failure could result in a fire.

• RECALL

  The air detector may not detect air bubbles consistently at the selected limit.

• RECALL

  The dialysis treatment may be run without the bicarbonate due to an undetected bicarbonate pump stall following a sodium change.

• RECALL

  Excess or insufficient ultrafiltration may occur during manual control of ultrafiltration via adjustment of transmembrane pressure (TMP)