CareFusion Alaris Medley SPO2 Module 8210
CareFusion · Model Alaris Medley SPO2 Module 8210
The SatSeconds™ Feature is an alarm management tool that allows you to configure the time that the %SpO2 level may fall outside the alarm limit before an audible alarm sounds. This feature was designed by Nellcor to reduce nuisance alarms. The Pre-Silence feature enables alarms to be pre-silenced for 120 seconds, but can be cancelled before the 120 seconds are complete. Safety throughout the duration of infusion therapy. Provides the unique ability to automatically pause a PCA infusion and deactivate the patient dose request cord if a patient falls below your hospital-defined % SpO2 limits when used with the Alaris® PCA module. Supports current ASA and APSF standards mandating monitoring of oxygenation for all appropriate patients.
Key tips
- ·Free-flow protection must be verified on every PM - a failed anti-free-flow clamp is a direct overdose risk.
- ·Test occlusion alarms in both directions - failing to alarm when it should is more dangerous than a false alarm.
- ·Battery run-time complaints are the most common real-world nuisance call - a full charge/discharge cycle test catches most of them.
Typical Failure Modes
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.
Failure / error message stops delivery
HighSymptoms: 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.
Occlusion alarm / pressure fault
MediumSymptoms: 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.
Air-in-line alarm
MediumSymptoms: Frequent air-in-line alarms, delivery stops.
Root cause: Air in the set, an improperly loaded set, or an ultrasonic air-detector fault.
Flow-rate accuracy drift
MediumSymptoms: Delivered volume outside tolerance on the annual test, especially at low rates.
Root cause: Worn pumping mechanism / plunger drive.
Battery will not hold charge
MediumSymptoms: Short run time, low-battery early after a full charge.
Root cause: Aged battery pack.
Door / plunger / sensor mechanical wear
LowSymptoms: Set will not load, door will not latch, plunger grip poor.
Root cause: Worn door latch, plunger jaws, or anti-free-flow mechanism.
Serviceable Parts & Consumables
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.
Battery pack
Class Periodic replacementRel. cost $$R&R Fairly easy
Pumping mechanism / rotor / plunger drive
Class Major service partRel. cost $$$R&R Difficult
Pressure / air-detector sensor assembly
Class Major service partRel. cost $$R&R Moderate
Door / latch / anti-free-flow assembly
Class Major service partRel. cost $$R&R Moderate
Drive motor / gearbox
Class Major service partRel. cost $$$R&R Difficult
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Battery pack | Periodic replacement | $$ | 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.
PM Checklist
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.
- ·Occlusion pressure and flow-rate accuracy verification
- ·Battery conditioning cycle
- ·Door latch and air-in-line sensor inspection
- ·Post-drop functional check before return to service
- ·Annual PM per manufacturer schedule
Troubleshooting Approach
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.
Symptom: Error message or code
- Note the exact error message / code.
- Look it up in the pump's technical service manual troubleshooting section.
- Use the biomed diagnostics / utilities to test the affected subsystem.
- Follow the manual's parts-replacement procedure.
- Run the scheduled-maintenance test set (including flow accuracy) after any repair.
Symptom: Occlusion or delivery problem
- Check the line for kinks, clamps and a closed roller clamp; check the patient site.
- Reload the set correctly, clearing all air.
- Confirm an approved set for this pump.
- Run the pressure / air-detector (or rotor) test in diagnostics.
- Replace the set; refer the pump if a sensor / mechanism fault is indicated.
Typical Location
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
- Patient care floors
- ICU
- OR
- Oncology / infusion centers
- Home health (portable pumps)
Documents & Manuals
Safety & Recalls
Synced live from the FDA openFDA API.
- RECALL
If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate; so dropped/jarred pumps should be removed from use, tested, and inspected by qualified service personnel prior to reuse; tip sheet, cleaning and disinfecting procedure and reference guide updated.
- RECALL
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.
- RECALL
During automated dispensing cabinet upgrade/installation/reimaging, component manager was left in installed mode, and if a Microsoft patch is then installed this may lead to an error preventing user access to the dispensing software application, which may lead to delay in access to medications/supplies, and delivery/replenishment of patient specific orders; which may lead to delay in patient care.
- RECALL
Antivirus software was not consistently installed on impacted devices during the implementation process.
- RECALL
Users trying to restock a single bin location of an automated dispensing cabinet, during pocket exchange restocking workflow, may experience a software issue that results in 2 destock transactions and 2 stock transactions, which results in doubling the bin quantity, which may result in a delay in access to desired medications and/or supplies, which may lead to temporary body function impairment.
- RECALL
Due to User Manual/Direction for Use incorrectly instructing user to leave the safety clamp in the open position when reloading an infusion set. This issue potentially could result in an accidental over infusion if the roller clamp is left open.
- RECALL
Pump Module keypad lifting, and Fluid ingress could result in 1) Unresponsive keys: module continues infusion, PC unit will not alarm and must be used for programming changes, may necessitate a different Pump Module. May result in infusion start delay/inability to titrate medication. 2) Stuck keys: PC unit alarms, module exhibits Channel Error, may result in infusion interruption/start delay
- RECALL
Infusion pump component defect may result in interruption of patient monitoring
- RECALL
Pump Module keypad may exhibit keys that are unresponsive or stuck as a result of fluid ingress potentially resulting in a delay to the start of infusion or interruption of infusion. Delays in an infusion or interruption can cause serious injury or death in high-risk patient populations.
- RECALL
Broken elements on pump module platen such as broken upper hinge post, lower hinge, and membrane frame can occur when the door is forcefully closed on an object, the device is dropped, or if improper cleaners are used on the membrane frame assembly. These may prevent devices from delivering accurate amounts of fluid, which may result in an over infusion, free-flow conditions, or under infusion.
- RECALL
LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.
- RECALL
Complaints where users were unable to prime the administration set.
- RECALL
The bezel manufacturing process for the FR-110 plastic may have resulted in its weakening. A bezel with weakened plastic may, over time, lead to separation of the bezel post (recall issue) as well as other damage to the bezel (i.e. external cracking). The separation of one or more bezel posts may result in free flow, over infusion, under infusion or interruption of infusion.
- RECALL
The recalling firm has received reports of increased or decreased flows that have occurred in certain pumps.
- RECALL
There is a potential risk that could cause unintended flow in the older, centered sear door latch design in the Alaris Pump module model 8100.
- RECALL
During an infusion, a false Air-in-Line (AIL) alarm would cause the infusion to be interrupted.
- RECALL
The Oral Airway pouch within the PINK/RED Oxygen Delivery Module, 7700RAW, was incorrectly packaged with the 8 cm Berman Oral Airway. The pouch contained within the module is correctly labeled as 5 cm but actually contains an 8 cm Berman Oral Airway component. Therefore, the component within the pouch is incorrect. The PINK/RED Oxygen Delivery Module, 7700RAW, is intended to be used within the PINK/RED Pouch of the BROSELOW pediatric safety system. Three (3) lots (lot# 914873, lot# 914876 and lot #914878) of the PINK/RED Oxygen Delivery Module, 7700RAW, are affected by this voluntary Field Safety Corrective Action.
- RECALL
CareFusion is recalling the Alaris EtCO2 module model 8300 because it may have been tested during service using a higher than specified concentration of CO2. The effect to the EtCO2 module tested with a higher concentration of CO2 could lead to an incorrect measurement of CO2.
- RECALL
CareFusion is recalling the Alaris Pump model 8100 version 9.1.18 because it may have a software issue that results in situation where the pump module will not properly delay an infusion when the "Delay Until" option or "Multidose" feature is used.
- RECALL
The recall was initiated because Carefusion identified a potential risk associated with the Alaris Pump module model 8100. Carefusion has received reports of customers experiencing motor stalls during infusion with Alaris Pump Module (model 8100) manufactured between August 2010 and July 2011.
- RECALL
The recall was initiated because Carefusion has identified a potential risk associated with the Alaris Pump module model 8100. The pump module door keypad overlay may separate from the keypad assembly
- RECALL
Under certain wireless network conditions a communication error can occur, which freezes the PC Unit screen, which may result in a delay of therapy. A delay of therapy may result in serious injury and/or death. CareFusion identified this potential risk associated with the Alaris PC unit model 8015 only (PC Unit) manufactured between December-2008 and September-2009.
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