# K041191: Colleague Volumetric Infusion Pumps

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Jun 25, 2004 after 50 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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 Pumps: named in the summary without a submission number

## Most influential descendants
- K070125: Colleague Guardian Configuration Tool; Colleague DL2 Event History Download Software Application (2007), 0 descendants of its own

## Recalls of this device
- Dec 6, 2006 · Not classified · Z-0483-2007: 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 t
- Dec 6, 2006 · Not classified · Z-0484-2007: 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 t
- Dec 13, 2005 · Not classified · Z-0445-06: 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 hea
- Dec 13, 2005 · Not classified · Z-0444-06: 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 hea
- Jul 20, 2005 · Not classified · Z-1059-05: A hardware problem can cause internal communications errors which halt therapies, generate alarms and communication failure codes.
- Jul 20, 2005 · Not classified · Z-1060-05: A hardware problem can cause internal communications errors which halt therapies, generate alarms and communication failure codes.
- Mar 15, 2005 · Not classified · Z-1023-05: 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.
- Mar 15, 2005 · Not classified · Z-1022-05: 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.
- Feb 25, 2005 · Not classified · Z-1544-05: 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 ext
- Feb 25, 2005 · Not classified · Z-1543-05: 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 ext

## Indications for use
Baxter Colleague Infusion Pumps are designed to meet the fluid delivery needs of today's clinically evolving health care environment. These pumps can be utilized for continuous or intermittent delivery through acceptable routes of administration such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural or irrigation of fluid spaces applications. Fluid delivery applications include: parenteral fluids, drugs and electrolytes (e.g. cardiovascular drugs, antibiotics, anesthetics, analgesics, etc.); and chemotherapy agents, total parenteral nutrition products, lipids, solutions for irrigation procedures, whole blood and blood products. Colleague Infusion Pumps are designed to travel the continuum of care, following the patient into a variety of care areas, including, but not limited to: Hospital: Post Anesthesia/Recovery - Blood Centers General Floor Cardiac Cath Lab Nuclear Medicine Medical/Surgical Emergency Room Hospice Critical/Intensive Care Areas Burn/Trauma Units Subacute Facilities Pediatrics/Neonatal Oncology Outpatient/Surgical Centers Labor/Delivery/Post Partum Mobile Intensive Care Long Term Care OR/Anesthesia Nursing Homes Homecare* *Colleague and Colleague CX pumps only.

Source page: https://510kreport.com/device/K041191
Methodology: https://510kreport.com/methodology