Cause of Device-Related Incident
Device factors; User errors

Clinical Specialty or Hospital Department
CCU / ICU / NICU; Nursing; Pharmacy / IV therapy

Device Factors
Design / labeling error; Packaging error

Document Type
Hazard Reports

External Factors
*Not stated

Mechanism of Injury or Death
Overdose

Support System Failures
*Not stated

Tampering and/or Sabotage
*Not stated

User Errors
Failure to perform pre-use inspection; Failure to read label; Inappropriate reliance on an automated feature

UMDNS
Transducers, Pressure, Disposable [16-909]; Pressure Monitoring Tubing Sets [15-640]

Mispackaging of Disposable Pressure Transducers and Continuous-Flush Devices



Hazard [Health Devices Jan 1993;22(1):29-30]

Problem

A member hospital reported an incident in which an adult patient received an overinfusion of saline through a 30 mL/hr continuous-flush device on a disposable pressure transducer set, which is usually used for neonates. The patient became hypervolemic, but was successfully treated.

The 30 mL/hr continuous-flush device involved in this incident was inadvertently used, instead of a 3 mL/hr device, when an employee retrieved it from a box of disposable pressure transducers that, according to its label, contained 3 mL/hr devices. In addition, it was packaged with an IV administration set, even though only 3 mL/hr devices of the model used in the reporting hospital are typically packaged with an administration set. The contents of the box were later inspected, and all remaining flush devices were of the 3 mL/hr size.

Clinical background

Continuous-flush devices are used to slowly flush the monitoring lines to minimize the possibility that blood clots will form within the catheter and at the catheter tip. Two types of continuous-flush devices are used in conjunction with disposable pressure transducers: 3 mL/hr devices, which are typically used for adult and pediatric patients, and 30 mL/hr devices, which are commonly used for neonates.

Adult (3 mL/hr) devices are used with an IV administration set that is connected to a pressurized bag of saline (the bag usually has heparin added to it). Pressure from the bag creates the flow through the IV administration set and flush device. The flow rate is slow enough to prevent overinfusion, but is fast enough to keep the transducer clear. The flush device also prevents the high pressure in the bag from interfering with the transducer measurement.

For neonatal applications, the flush device is connected to an infusion pump instead of directly to the administration set and IV bag to ensure adequate control of flow. (Neonates require a much more precise control of flow than adults because even a small, unintentional overinfusion could lead to serious fluid overload.) When an infusion pump is used, a higher-flow-capability (i.e., 30 mL/hr) flush device is required to prevent the high back pressures that cause occlusion alarms on the pump. Although neonatal continuous-flush devices allow flows of up to 30 mL/hr without excessive back pressure, flows will normally be set much lower (usually under 3 mL/hr) for continuous infusion.

Another reason that neonatal applications require higher-flow-capability devices is that neonates will often have only one arterial access, which must be used for both administering IV therapy and monitoring pressure. In this case, flow rates may exceed 3 mL/hr, and flow would be blocked by a standard adult flush device.

Discussion

The use of mispackaged flush devices can be avoided if the personnel that use them learn how to identify the flow rates by visual inspection. Most vendors indicate either the device's flow rate or its intended use (i.e., for adult or neonatal applications) on the package insert. However, although they do not note this anywhere, most vendors also color code their devices to readily indicate whether the device is 3 or 30 mL/hr. The color-coded pull/squeeze tabs or buttons make identification of the type of device easy, even without the package insert.

For most vendors, the 3 mL/hr adult devices are either white or clear, and the 30 mL/hr neonatal devices are typically yellow (however, one vendor uses orange). Some vendors will supply custom colors for their adult devices; however, they will never use their neonatal device color, which does not vary, for the adult devices. Also, at least one vendor identifies one of its devices by imprinting the flow rate on the device instead of using a color code.

Color coding also enables personnel to perform case-by-case quality inspections to ensure that the labeling is correct before the devices are used on patients. Any discrepancy between the color code and the package insert should be questioned with the vendor before the device is put into use.

ECRI comments

We believe that manufacturers should work together to devise a universal method of identification (e.g., a color standard) for these devices.

Recommendations

  1. Notify users of continuous-flush devices that two different devices with different flow rates exist and that the neonatal device has the higher flow rate. Users should also be aware that mispackaging can occur and that the device's flow rate should be visually confirmed before use.
  2. Check with your vendor to determine the color code used on its devices.
  3. Instruct users (by placarding supply areas) how to verify the flow rate of the device by comparing its colored tab or button against the color code used by the supplier in your hospital.

UMDNS Terms

  • Transducers, Pressure, Disposable [16-909]
  • Pressure Monitoring Tubing Sets [15-640]

Cause of Device-Related Incident

Device factors: Design/labeling error; Packaging error

User errors: Failure to perform pre-use inspection; Failure to read label; Inappropriate reliance on an automated feature

Mechanism of Injury or Death

Overdose


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