# K063696: Colleague Volumetric Infusion Pump Model# 2M8151,8153,8161,8163,9161,9163

- Pathway: 510(k) (Traditional)
- Applicant: Baxterhealthcare, Inc.
- Decided: Feb 27, 2007 after 76 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 19 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) COLLEAGUE Volumetric Infusion Pump (currently marketed models: COLLEAGUE, COLLEAGUE CX, COLLEAGUE 3, COLLEAGUE 3 CX): named in the summary without a submission number

## Recalls of this device
- Jul 22, 2011 · Not classified · Z-2958-2011: 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
- Jul 22, 2011 · Not classified · Z-3007-2011: 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 initiat
- Jul 22, 2011 · Not classified · Z-3008-2011: 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.
- Jul 5, 2011 · Not classified · Z-2853-2011: 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 p
- May 4, 2011 · Not classified · Z-2796-2011: The Air In Line (AIL) test was not properly performed by the service technician at the Service Center.
- Apr 14, 2011 · Not classified · Z-2222-2011: The Hi-Pot safety testing may not have been conducted on the affected pumps during service, prior to being returned to the end user.
- Dec 1, 2010 · Not classified · Z-0935-2011: The Air In Line (AIL) test was not properly performed by the service technician at the Service Center.
- Dec 1, 2010 · Not classified · Z-0931-2011: While the infusion pump was being serviced at the Baxter Service Center, it was inadvertently routed to the packaging area before the final inspection.
- Aug 4, 2010 · Not classified · Z-0001-2011: 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 determine
- Aug 4, 2010 · Not classified · Z-0002-2011: 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 determine
- Jul 14, 2010 · Not classified · Z-0744-2012: 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.
- Jul 14, 2010 · Not classified · Z-0745-2012: 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.
- May 8, 2009 · Not classified · Z-0598-2012: There was no documentation to show the required tests were performed following the replacement of the battery and battery harness.
- Jan 23, 2009 · Not classified · Z-1038-2009: Baxter has identified failure codes that lead to a delay or an interruption of therapy, hazards associated with improper cleaning, and damaged battery messages for the Colleague Infusion Pumps.
- Jan 23, 2009 · Not classified · Z-1037-2009: 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.
- Aug 15, 2007 · Not classified · Z-1224-2007: Some of the pumps were upgraded by one service technician who failed to replace prisms and batteries as required in the upgrade.
- Jun 21, 2007 · Not classified · Z-1114-2007: Falsified Repair/Test and Inspection records: Pumps submitted for repair or service may not have been properly repaired or serviced before being returned to the customer.
- Jun 21, 2007 · Not classified · Z-1113-2007: Falsified Repair/Test and Inspection records: Pumps submitted for repair or service may not have been properly repaired or serviced before being returned to the customer.
- Jun 20, 2007 · Not classified · Z-1091-2007: 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 a

## Indications for use
The COLLEAGUE Volumetric Infusion Pump is capable of delivering medications, solutions, parenteral nutrition, lipids, blood and blood components. The COLLEAGUE pump is designed to deliver infusion therapies via clinically acceptable routes of administration, including intravenous, intra-arterial, epidural, and subcutaneous routes. The COLLEAGUE pump is intended for use in a wide variety of patient care environments for adult, pediatric and neonatal patients. The COLLEAGUE pump facilitates the delivery of routine and critical infusion therapies via continuous and intermittent delivery using primary and piggyback, infusion modes. The COLLEAGUE pump can be used in the following care areas: * General Floor of the Hospital * Critical / Intensive Care * Neonatal Intensive Care * Pediatric Care * Labor / Delivery / Postpartum * Operating Room / Anesthesia * Post Anesthesia / Recovery * Cardiac Catheterization Lab * Emergency Room * Ground Ambulance * Hospice Facility * Outpatient / Subacute Facilities * Nursing Facilities * Long Term Care / Rehabilitation Facilities * Diagnostic Nuclear Medicine * Oncology Floor * Burn Unit / Trauma

Source page: https://510kreport.com/device/K063696
Methodology: https://510kreport.com/methodology