Baxter SYNDEO PCA Syringe Pump

Technical Specs

Infusion Pump Type

Patient-Controlled Analgesic (PCA)

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

• Baxter Syndeo PCA User ManualUser Manual · External

Safety & Recalls

Synced live from the FDA openFDA API.

• RECALL

  A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.

• RECALL

  Baxter is issuing an Urgent Medical Device Correction for the Novum IQ large volume pump (LVP) due to the potential for underinfusion when transitioning from a flow rate to a higher flow rate that is more than double. (e.g., rate change or bolus). The level of underinfusion is variable based on the current infusion rate, the duration the pump has been running at this flow rate, and the magnitude of the rate change. The longer the duration the pump has been running at the current infusion rate and the larger the magnitude of the rate change, the larger the underinfusion that would be experienced. Additionally, Baxter has identified an increase in customer reports of over and underinfusion potentially due to set misloading. Failure to properly load the tubing into the pump channel may result in the pump infusing at a rate higher or lower than programmed. Consistent with the instructions

• RECALL

  Baxter has identified a design issue which may cause the pump to detect the presence of a syringe flange when no syringe is loaded. When this issue occurs, the pumps 'user interface becomes stuck on the "Remove Syringe" screen when an infusion is complete, and the syringe is unloaded. A System Error 21502 (Flange Sensor Failure) may occur. Please note this issue only affects a subset of Novum IQ syringe pumps manufactured or repaired after July 4, 2023.

• RECALL

  Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Novum IQ syringe pumps listed below due to an incorrectly installed gasket. A gasket failure could lead to potential fluid ingress due to cleaning, or as a result of an IV fluid spill.

• RECALL

  Baxter is issuing an Urgent Medical Device Correction for the Novum IQ Syringe Pump. Baxter identified that after multiple downstream occlusion alarms, the pump may display an Infusion Complete alarm even though uninfused fluid remains in the syringe.

• RECALL

  There is a potential of the packaging not maintaining a sterile barrier for the tip caps.

• RECALL

  Product is mislabeled as self-righting Luer slip tip caps, yellow.

• RECALL

  Variability in the performance of the tubing in the ARPS (Automatic Repositioning System) Pump Assembly which may lead to alarm situations during system self-test and therapy. This tubing is normally replaced during annual preventative maintenance. Alarm Situations: During System Self-Test: Alarm code B1215 (ARPS Self-Test failure); During Therapy: B1273 (ARPS Leak), B1215 (ARPS Pressure self-test), B1116 (Return Pressure self-test Failure), B1539 (Access Pod Reposition Failure), B1541 (Effluent Pod Reposition Failure), B1540 (Effluent Filter Pod Reposition Failure). If an alarm occurs, it may lead to delay or interruption of therapy. In the event that therapy is terminated without returning blood to the patient, blood loss may occur.

• RECALL

  Baxter Healthcare Corporation is issuing a voluntary product recall for all unexpired lots of the 50mm 0.2 Micron Filter (Product Code: H93835) due to the potential for the filter membrane layer to be missing and for particulate matter to be present.

• RECALL

  All lots of RAPIDFILL Syringe Strips lack evidence supporting the packaging claim for 12-month shelf life on released product.

• RECALL

  Self-Righting Luer Tip Caps were manufactured and shipped with a missing latex symbol on both single and case labels.

• RECALL

  Baxter Corporation initiated a recall of two lots of Self-Righting Luer Lock Tip Caps because they were distributed prior to closure of the validation.

• RECALL

  One Service Technician may not have correctly serviced specific Sigma Spectrum Infusion Pumps according to established procedures during the time period of 5/5/2014 through 6/3/2014.

• RECALL

  Possible breach in sterile barrier for inner and outer bags of the product.

• RECALL

  Should a battery with the minimum contact diameter (.51 inches) be placed on the battery spring (.53 inches), an electrical circuit will not be completed and the Mini-Infuser will not operate. The reason being that the Mini-Infuser Battery Spring has a flat contact that measures .53 inches .01 inches on the inner diameter of the spring coil. The IEC 60086-2 and ANSI 08 standards specify a minimum

• RECALL

  Should a battery with the minimum contact diameter (.51 inches) be placed on the battery spring (.53 inches), an electrical circuit will not be completed and the InfusOR will not operate. The reason being that the InfusOR (2L3100) Battery Spring has a flat contact that measures .53 inches .01 inches on the inner diameter of the spring coil. The IEC 60086-2 and ANSI 08 standards specify a minimum

• RECALL

  Non-conforming Electrostatic Discharge (ESD) grounding squares may cause the pump to be susceptible to shorting-out of circuitry, resulting in a loss of audio, and/or interruption of therapy.

• RECALL

  The occlusion detection and alarm may be delayed when the pumps are used with larger volume syringes at low flow rates.

• RECALL

  A non-conforming gasket was used in manufacturing of the specific pumps, causing the pumps to be more susceptible to electro-static discharge, which could increase the potential for the pump to fail during use and alarm.

• RECALL

  Advisory to alert users to assure that the hemofilter of the blood line is in the horizontal position to avoid kinking of the bloodline tubing to avoid hemolysis, and to show the compatible blood tubing sets to be used with the BM11/BM11A Blood Monitor Pump and BM25 System ultrafiltration hemodialysis system.

• RECALL

  During an infusion in the 'Basal + PCA' or 'PCA only' modes, the SYNDEO pump may generate false Service Code 919 or Service Code 920, which will cause the pump to stop the infusion. Also, while attempting to turn on the device by pressing the On/Off key, the pump may not power up properly.

• RECALL

  A 'Check Flange' alarm may occur even though the syringe has been properly loaded into the AS50 Infusion Pump. The false alarm may occur during the syringe loading process or while an infusion is running. Also, the occlusion detection and alarm may be delayed when the pumps are used with larger volume syringes at low flow rates.

• RECALL

  Possible occlusion of the Clearlink injection site valve due to inadequate silicone lubrication of the slit in the upper seal of the valve.

• RECALL

  The pump may free-flow if the door to the 6060 pump is not closed prior to loading the pump in to the lock box. The pump will alarm 'Door Open', but if the pump is turned off to silence the alarm while remaining in the lock box, the fluid will free-flow.

• RECALL

  Leakage may occur at the inlet port

• RECALL

  Sterility questioned

• RECALL

  The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.

Related calculators

From BioLab, for work done with this kind of equipment.

• IV Flow RatemL per hour from a volume and a time, or time and volume from a rate
• Drip RateDrops per minute for a gravity infusion set
• Weight-Based Infusion RatePump rate from a dose per kg per minute and a concentration