
Baxter International · Model Colleague Single
Colleague pumps are only available and supported outside the US, as of July 14, 2012. The Baxter Colleague 1 Volumetric Infusion Pump can be utilized for continuous or intermittent delivery through clinically acceptable routes of administration, such as intravenous, intra-arterial, subcutaneous, epidural, or irrigation of fluid spaces applications.
Compiled for this model from its own documentation and established engineering knowledge for this equipment class - not from a verified service record. Confirm against the manufacturer's service manual.
Symptoms: The pump alarms and displays an error message / code and stops.
Root cause: A subsystem fault indexed in the service manual - motor / drive, a sensor, set-detection, or a board.
Symptoms: Repeated occlusion alarms, delivery stops, or an occlusion is missed.
Root cause: Kinked or clamped line, a closed roller clamp, a positional patient tube, pressure-sensor drift, or an improperly loaded set.
Symptoms: Frequent air-in-line alarms, delivery stops.
Root cause: Air in the set, an improperly loaded set, or an ultrasonic air-detector fault.
Symptoms: Delivered volume outside tolerance on the annual test, especially at low rates.
Root cause: Worn pumping mechanism / plunger drive.
Symptoms: Short run time, low-battery early after a full charge.
Root cause: Aged battery pack.
Symptoms: Set will not load, door will not latch, plunger grip poor.
Root cause: Worn door latch, plunger jaws, or anti-free-flow mechanism.
Serviceable items for this model, compiled from its documentation and engineering knowledge for this equipment class. Service class and relative cost are estimates, not manufacturer figures; no part numbers are given. Confirm intervals and pricing against the manufacturer.
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Battery pack | Periodic replacement | $$ | Fairly easy |
| Pumping mechanism / rotor / plunger drive | Major service part | $$$ | Difficult |
| Pressure / air-detector sensor assembly | Major service part | $$ | Moderate |
| Door / latch / anti-free-flow assembly | Major service part | $$ | Moderate |
| Drive motor / gearbox | Major service part | $$$ | Difficult |
Relative cost: $ lowest · $$$$ highest service-part cost for this equipment class. Not a price.
Preventive-maintenance tasks typical of this equipment class. Perform to the manufacturer's procedure and your facility's policy - this is general reference, not a schedule for this specific unit.
A starting sequence for this model, compiled from its documentation and engineering knowledge for this equipment class. Follow the manufacturer's service documentation for the actual procedure.
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
Synced live from the FDA openFDA API.
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.
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.
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
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.
There were customer reports of separation between the tubing and Male Luer Lock Adaptor.
Instructions for use booklet may puncture the outer Tyvek lid.
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.
Potential for device malfunction resulting in flow when the device should not be flowing
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
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.
Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.
The Tina System was released to the customer with OOS values for the Pressure Displays Accuracy and Leakage Rate Test.
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
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.
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.
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.
The Hi-Pot safety testing may not have been conducted on the affected pumps during service, prior to being returned to the end user.
While the infusion pump was being serviced at the Baxter Service Center, it was inadvertently routed to the packaging area before the final inspection.
The Air In Line (AIL) test was not properly performed by the service technician at the Service Center.
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
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.
Some of the 1550 Hemodialysis Instruments may have replacement circuit boards with incorrect versions of software.
There was no documentation to show the required tests were performed following the replacement of the battery and battery harness.
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.
Some of the pumps were upgraded by one service technician who failed to replace prisms and batteries as required in the upgrade.
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.
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.
A hardware problem can cause internal communications errors which halt therapies, generate alarms and communication failure codes.
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.
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.
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.
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.
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.
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.
The air detector may not detect air bubbles consistently at the selected limit.
The dialysis treatment may be run without the bicarbonate due to an undetected bicarbonate pump stall following a sodium change.
Excess or insufficient ultrafiltration may occur during manual control of ultrafiltration via adjustment of transmembrane pressure (TMP)
From BioLab, for work done with this kind of equipment.
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