Examples of Medical Device Misconnections | FDA

Examples of Medical Device Misconnections | FDA https://www.fda.gov/medical-devices/medical-device-connectors/exampl...

In order to physically prevent device misconnections from occurring, standardized connector designs for specific medical applications are being developed. FDA expects manufacturers will begin producing devices with new connectors that conform to these design standards.

These new connectors are designed to help reduce the risk for medical device misconnections like the examples in these case studies. As new connector designs for high-risk delivery systems become available, the likelihood for medical device misconnections is expected to decrease. For currently marketed devices that do not incorporate the new standards, misconnections can still occur. Until new connector designs enter the market, these case studies offer providers and patients important tips and recommendations to prevent device misconnections.

These case studies are based on reports of adverse events received by the FDA. The potential for harm designations: High, Medium and Low refer to the severity of patient harm that could result from the depicted type of misconnection.

These case studies can be used without permission from the FDA. They are a product of the U.S. Federal Government and are not copyrighted or restricted in any way.

Examples of Medical Device Misconnections | FDA https://www.fda.gov/medical-devices/medical-device-connectors/exampl...

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CASE STUDY

An anesthetist and a midwife mistakenly connected an epidural set to the patient’s IV tubing The epidural medicine was delivered to the IV The patient died

POTENTIAL FOR HARM: High

THE JOINT COMMISSION SAFETY TIP: For certain high-risk catheters (e.g., epidural, intrathecal, arterial), label the catheter and do not use catheters that have injection ports

Examples of Medical Device Misconnections | FDA https://www.fda.gov/medical-devices/medical-device-connectors/exampl...

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CASE STUDY

A child in a pediatric intensive care unit had both an IV line and a trach tube The IV tubing was mistakenly connected to the trach cuff port The IV fluid over-expanded the trach cuff to the point of breaking and continuous IV fluids entered the child’s lungs The child died

POTENTIAL FOR HARM: High

THE JOINT COMMISSION SAFETY TIP: Emphasize the risk of tubing misconnections

in orientation and training

EVENT: CASE STUDY

During a nebulizer treatment, the patient’s oxygen tubing fell off the nebulizer and the patient’s IV tubing was inadvertently attached to the nebulizer When the patient inhaled, a moderate amount of IV fluids was aspirated into the

Examples of Medical Device Misconnections | FDA https://www.fda.gov/medical-devices/medical-device-connectors/exampl...

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patient’s lungs The misconnection was identified by the respiratory therapist and the patient survived

POTENTIAL FOR HARM: High

THE JOINT COMMISSION SAFETY TIP: Do not purchase non-intravenous equipment

that is equipped with connectors that can physically mate or attach with a female Luer IV line connector

CASE STUDY

A patient’s oxygen tubing became disconnected from his nebulizer and was accidentally reattached to his IV tubing Y-site by a staff member who was completing a double shift The patient died from an air embolism, even though the connection was broken within seconds

POTENTIAL FOR HARM: High