# K041550: Hospira Phoenix Infusion System with Hospira Mednet Software

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jun 30, 2004 after 21 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 36 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K011442 (2001). 4 ancestors in all.
13 later devices descend from it; 2 cite it directly.
7 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031185: Abbott Plum a+ Infusion Pump with a HPL/RS Plug-and-Play Module, Abbott Laboratories (2003) Summary page 1.
- K023062: Gemstar Infusion Pump System, 7 Therapy, 6 Therapy & Pain Management, Abbott Laboratories, Inc. (2002) Summary page 1.

## Most influential descendants
- K103344: Infusion Sets (2010), 10 descendants of its own
- K141789: Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0 Module for Plum a+ Infusion System Upgrade (2015), 9 descendants of its own
- K161469: Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module (2017), 5 descendants of its own
- K223607: Plum Duo™ Infusion System (2023), 2 descendants of its own
- K153074: Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal (2016), 2 descendants of its own

## Recalls of this device
- Feb 4, 2013 · Class II · Z-2056-2016: Frequent Proximal Occlusion Alarms (POAs) occurring on Symbiq devices with list numbers 16026 and 16027. When there are false alarms, the pump will continue to alarm even though there is no occlusion 
- Feb 4, 2013 · Class II · Z-2055-2016: Frequent Proximal Occlusion Alarms (POAs) occurring on Symbiq devices with list numbers 16026 and 16027. When there are false alarms, the pump will continue to alarm even though there is no occlusion 
- Aug 29, 2012 · Class I · Z-0069-2013: The Symbiq pump touchscreen may not respond to user selection, may experience a delayed response, or may register a different value from the value selected by the user. Failure of the touchscreen to r
- Aug 29, 2012 · Class I · Z-0070-2013: The Symbiq pump touchscreen may not respond to user selection, may experience a delayed response, or may register a different value from the value selected by the user. Failure of the touchscreen to r
- Mar 16, 2011 · Class II · Z-0362-2017: May go to a white screen due to a problem with the SOM2 module. A white screen is a diagnostic screen displayed to the user as part of the safety shutdown procedure of the device. The infusion and the
- Mar 16, 2011 · Class II · Z-0361-2017: May go to a white screen due to a problem with the SOM2 module. A white screen is a diagnostic screen displayed to the user as part of the safety shutdown procedure of the device. The infusion and the
- Apr 9, 2010 · Not classified · Z-1895-2010: Hospira has received numerous customer complaints of the Symbiq infusion pump's failure to detect air-in-line conditions during operation.
- Apr 9, 2010 · Not classified · Z-1894-2010: Hospira has received numerous customer complaints of the Symbiq infusion pump's failure to detect air-in-line conditions during operation.
- Mar 26, 2010 · Not classified · Z-2381-2010: If the administrator set is removed prior to the cassette carriage fully opening without closing the slide/roller clamp, unrestricted flow and delivery may result.
- Feb 22, 2010 · Not classified · Z-0127-2011: Hospira has identified motor encoder failures in the Symbiq pumping mechanism that causes the infuser to cease operation during infusion therapy, resulting in delay or interruption of infusion therapy
- Feb 22, 2010 · Not classified · Z-0128-2011: Hospira has identified motor encoder failures in the Symbiq pumping mechanism that causes the infuser to cease operation during infusion therapy, resulting in delay or interruption of infusion therapy
- Feb 22, 2010 · Not classified · Z-2391-2010: The clamp may not secure to the IV pole and the pump may slip or fall off. The pump may fall on a person or pull the tubing out of the IV container.
- Feb 22, 2010 · Not classified · Z-2390-2010: The clamp may not secure to the IV pole and the pump may slip or fall off. The pump may fall on a person or pull the tubing out of the IV container.
- Jan 8, 2010 · Not classified · Z-0808-2010: There is a potential for fluid to leak from the backcheck valve which could result in inaccurate delivery and occupational exposure.
- Nov 24, 2009 · Not classified · Z-1053-2010: Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets.
- Nov 24, 2009 · Not classified · Z-1045-2010: Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets.
- Nov 24, 2009 · Not classified · Z-1050-2010: Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets.
- Nov 24, 2009 · Not classified · Z-1052-2010: Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets.
- Nov 24, 2009 · Not classified · Z-1055-2010: Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets.
- Nov 24, 2009 · Not classified · Z-1056-2010: Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets.
- Nov 24, 2009 · Not classified · Z-1058-2010: Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets.
- Nov 24, 2009 · Not classified · Z-1061-2010: Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets.
- Nov 24, 2009 · Not classified · Z-1062-2010: Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets.
- Nov 24, 2009 · Not classified · Z-1063-2010: Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets.
- Nov 24, 2009 · Not classified · Z-1046-2010: Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets.
- Nov 24, 2009 · Not classified · Z-1047-2010: Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets.
- Nov 24, 2009 · Not classified · Z-1048-2010: Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets.
- Nov 24, 2009 · Not classified · Z-1049-2010: Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets.
- Nov 24, 2009 · Not classified · Z-1051-2010: Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets.
- Nov 24, 2009 · Not classified · Z-1054-2010: Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets.
- Nov 24, 2009 · Not classified · Z-1057-2010: Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets.
- Nov 24, 2009 · Not classified · Z-1059-2010: Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets.
- Nov 24, 2009 · Not classified · Z-1060-2010: Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets.
- Mar 31, 2009 · Not classified · Z-1816-2009: Potential delay/underinfusion of critical therapy-- Devices experience increased frequency of alarms that result in temporary pump stoppage.
- Mar 31, 2009 · Not classified · Z-1815-2009: Potential delay/underinfusion of critical therapy-- Devices experience increased frequency of alarms that result in temporary pump stoppage.
- Dec 3, 2008 · Not classified · Z-0944-2009: Hypersensitivity to normal motor friction/drag may cause malfunction errors and alarms that are designed to stop pump operations.

## Indications for use
The Hospira Phoenix Infusion System with Hospira MedNet Software is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural or irrigation routes of administration. It is intended primarily for use in the hospital setting and can be used in other acute and non-acute care areas, such as, but not limited to Home Care, Nursing Homes, Mobile Intensive Care, Ambulatory Infusion Centers, Hospice, Subacute facilities, Outpatient/Surgical Centers, Long Term Care, Urgent Care, Transport and Physician Offices.

Source page: https://510kreport.com/device/K041550
Methodology: https://510kreport.com/methodology