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Even the Simplest Devices May Malfunction: Split Septum Design Revisited.
Biomedical Instrumentation & Technology
|March 10, 2021
Summary
Needle-free IV connectors can fail when the split septum malfunctions, preventing fluid flow. This medical device failure necessitates clinical vigilance to prevent patient harm and unnecessary procedures.
Area of Science:
- Medical Devices
- Clinical Engineering
- Patient Safety
Background:
- Split septum devices are integral to needle-free intravenous (IV) fluid administration systems.
- These devices are designed to allow unidirectional fluid flow and prevent blood reflux.
Purpose of the Study:
- To report a critical malfunction of a Luer-access split septum needle-free connector.
- To highlight the potential for adverse events resulting from medical device failure.
Main Methods:
- Case report detailing the malfunction of a split septum needle-free connector extension set.
- Clinical observation of device failure in multiple patients.
Main Results:
- Complete failure of the split septum device occurred due to the septum remaining fused and unsplit.
- This malfunction led to an adverse event involving repeated, unnecessary IV insertion attempts in a patient.
Conclusions:
- Even simple medical devices like split septum connectors can malfunction.
- Clinical vigilance is crucial to identify and mitigate risks associated with medical device failures.
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