# K060806: Hospira Gemstar Infusion Pump System, 7 Therapy, Model 13087; 6 Therapy, Model 13086; Pain Management, Model 13088

- Pathway: 510(k) (Special)
- Applicant: Hospira, Inc.
- Decided: Apr 21, 2006 after 28 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 25 (7 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K023062 (2002). 2 ancestors in all.
12 later devices descend from it; 2 cite it directly.
7 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051079: Hospira Gemstar Infusion Pump System with Hospira Gemstar Spring Assist Mechanism Lockbox-7 Therapy, Hospicare, Inc. (2005) Summary page 2.
- K023062: Gemstar Infusion Pump System, 7 Therapy, 6 Therapy & Pain Management, Abbott Laboratories, Inc. (2002) Summary page 2.

## Cited in the summary but kept off the family tree
- K041739: Edwards E360 Surgical Ablation Device, Edwards Lifesciences, LLC (2004). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K103224: Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe Tubing (2011), 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 18, 2014 · Class I · Z-1512-2014: There are two situations that may occur when using the GemStar Docking Station, List Number 13075-XX-XX, in conjunction with the GemStar infusion pump: 1) when the Docking Station is used in conjuncti
- Feb 3, 2014 · Class I · Z-0095-2015: The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one instance, smoke was observed and the GemStar pump was operating on battery power while connected to th
- Feb 3, 2014 · Class I · Z-0096-2015: The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one instance, smoke was observed and the GemStar pump was operating on battery power while connected to th
- Jan 31, 2014 · Class II · Z-2031-2014: The connection between the beeper subassembly and the pump may fail. The GemStar infusion pump will identify this failure during the "self-test" while powering up which will result in a Beeper Error (
- Mar 21, 2013 · Class II · Z-1116-2013: During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medication resulting in over-infusion.
- Mar 21, 2013 · Class II · Z-1117-2013: During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medication resulting in over-infusion.
- Mar 19, 2013 · Class II · Z-0421-2015: Some patients are obtaining access to the dosage reset codes required to change the settings on GemStar infusion pumps and are subsequently changing the infusion rate set by their doctors. Patients ar
- Mar 19, 2013 · Class II · Z-0422-2015: Some patients are obtaining access to the dosage reset codes required to change the settings on GemStar infusion pumps and are subsequently changing the infusion rate set by their doctors. Patients ar
- Mar 18, 2013 · Class I · Z-1159-2013: Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy's parameters and causes an 11/004 error resulting in the pump not being able to be used.
- Mar 18, 2013 · Class I · Z-1160-2013: Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy's parameters and causes an 11/004 error resulting in the pump not being able to be used.
- Mar 18, 2013 · Class I · Z-1169-2013: Pump shutting off during use without warning.
- Mar 15, 2013 · Class I · Z-0349-2014: The proximal and distal pressure sensor calibration can drift resulting in the pump failing the Proximal or Distal Occlusion Operational Test, as described in the GemStar Technical Service Manual, or 
- Mar 28, 2012 · Not classified · Z-1463-2012: Hospira has received customer reports of bolus delivery failures when using the GemStar bolus cord. Possible failures may be a result of cracked or damaged bolus cords which may result in an open or s
- Aug 12, 2010 · Not classified · Z-2633-2010: Underdelivery of infusion during clinical use at low rate settings (less than 10 mL/hour). Patient may not receive the intended amount of medication.
- Aug 12, 2010 · Not classified · Z-2632-2010: Underdelivery of infusion during clinical use at low rate settings (less than 10 mL/hour). Patient may not receive the intended amount of medication..
- Aug 12, 2010 · Not classified · Z-2629-2010: Underdelivery of infusion during clinical use at low rate settings (less than 10 mL/hour). Patient may not receive the intended amount of medication.
- Aug 12, 2010 · Not classified · Z-2628-2010: Underdelivery of infusion during clinical use at low rate settings (less than 10 mL/hour). Patient may not receive the intended amount of medication.
- Aug 12, 2010 · Not classified · Z-2630-2010: Underdelivery of infusion during clinical use at low rate settings (less than 10 mL/hour). Patient may not receive the intended amount of medication.
- Aug 12, 2010 · Not classified · Z-2627-2010: Underdelivery of infusion during clinical use at low rate settings (less than 10 mL/hour). Patient may not receive the intended amount of medication.
- Aug 12, 2010 · Not classified · Z-2631-2010: Underdelivery of infusion during clinical use at low rate settings (less than 10 mL/hour). Patient may not receive the intended amount of medication.
- Nov 24, 2009 · Not classified · Z-1337-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1338-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Nov 24, 2009 · Not classified · Z-1339-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.
- Aug 11, 2009 · Not classified · Z-0014-2010: Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.
- Aug 11, 2009 · Not classified · Z-0015-2010: Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.

## Indications for use
The Hospira GemStar® Infusion Pump System is intended for use in intravenous arterial, subcutaneous, short term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products. The indications for use include hospital, ambulatory, and home care environments. The pump must be used with sterile, dedicated, GemStar® administration sets.

Source page: https://510kreport.com/device/K060806
Methodology: https://510kreport.com/methodology