Medical Devices Misconnections

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. 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 .........................................Continued...........................................................