Examples of Medical Device 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.
Epidural tubing erroneously connected to IV tubing
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
IV tubing erroneously connected to trach cuff
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
IV tubing erroneously connected to nebulizer
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 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
Oxygen tubing erroneously connected to a needleless IV port
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
THE JOINT COMMISSION SAFETY TIP: Identify and manage conditions and practices that may contribute to health care worker fatigue, and take appropriate action
Blood pressure tubing erroneously connected to IV catheter
CASE STUDY
- An ER patient had an IV heparin lock but no IV fluids had been started. The patient also had a noninvasive automatic BP cuff placed for continuous monitoring
- The BP cuff tubing was disconnected when the patient went to the bathroom
- When she returned, her spouse mistakenly connected the BP cuff tubing to the IV catheter and approximately 15 mL of air was delivered to the IV catheter
- The patient died from a fatal air embolus, despite resuscitation efforts
POTENTIAL FOR HARM: High
Inform non-clinical staff, patients and their families that they must get help from clinical staff whenever there is a real or perceived need to connect or disconnect devices or infusions
IV tubing erroneously connected to nasal cannula
CASE STUDY
- A nurse’s aide inadvertently connected a patient’s IV tubing to the nasal oxygen cannula upon transfer to the step down unit
- The misconnection was not noted until four hours later, when the patient complained of chest tightness and difficulty breathing
- The patient was treated for congestive heart failure and survived
POTENTIAL FOR HARM: High
THE JOINT COMMISSION SAFETY TIP: Recheck connections and trace all patient tubes and catheters to their sources upon the patient’s arrival in a new setting or service as part of the handoff process. Standardize this “line reconciliation” process.
Syringe erroneously connected to trach cuff
CASE STUDY
- The patient had both a central line with three ports and a trach tube
- Medicine intended for the central line was inadvertently injected into the trach cuff
- The trach cuff was damaged and the medicine entered the patient’s lungs
- A new trach tube was inserted and the patient survived
POTENTIAL FOR HARM: High
THE JOINT COMMISSION SAFETY TIP: Always trace a tube or catheter from the patient to the point of origin before connecting any new device or infusion
Enteral feeding tube erroneously connected to ventilator in-line suction catheter
CASE STUDY
- A patient’s feeding tube was inadvertently connected to the instillation port on the ventilator in-line suction catheter
- Tube feeding was delivered into the patient’s lungs
- The patient died
POTENTIAL FOR HARM: High
Emphasize the risk of tubing misconnections in orientation and training
Pulsatile anti-embolism stocking erroneously connected to IV heparin lock
CASE STUDY
- A patient admitted for stroke had a pulsatile anti-embolism stocking (PAS) on the left lower extremity and an IV heparin lock in the right ankle
- The patient was alert and oriented on admission but shortly after was found unresponsive and cyanotic
- The PAS pump tubing was found connected to the IV heparin lock in the patient’s right ankle
- The patient died of a massive air embolus
POTENTIAL FOR HARM: High
THE JOINT COMMISSION SAFETY TIP: Manufacturers should implement “designed incompatibility” as appropriate, to prevent dangerous misconnections of tubes and catheters
IV tubing erroneously connected to enteral feeding tube
CASE STUDY
- A child had both a gastric feeding tube for nutrition and an IV for medicine and hydration
- When the child’s gown was changed, a family member inadvertently attached the IV tubing to the gastric feeding tube
- The medicine was delivered through the feeding tube into the stomach
- There was no patient harm since the event was noted in a timely manner
POTENTIAL FOR HARM: Moderate
THE JOINT COMMISSION SAFETY TIP: Inform non-clinical staff, patients and their families that they must get help from clinical staff whenever there is a real or perceived need to connect or disconnect devices or infusions
Foley catheter erroneously connected to NG tube
CASE STUDY
- A patient was found with her Foley catheter disconnected from its drainage bag. One end of the catheter was still in her bladder and the other end was connected to her nasogastric (NG) tube
- Urine was noted to be flowing into her NG tube
- The NG tube was connected to suction and more than 300 mL of urine drained
- The patient’s vital signs were stable and her laboratory results were within normal limits
POTENTIAL FOR HARM: Low
Inform non-clinical staff, patients and their families that they must get help from clinical staff whenever there is a real or perceived need to connect or disconnect devices or infusions.
Air-filled syringe for limb tourniquet cuff erroneously connected to introducer sheath
CASE STUDY
- Before removing the arterial sheath from the radial artery, a clinician mistakenly injected air into the arterial sheath instead of into the air inflation port for the tourniquet cuff.
- Air was injected directly into the patient’s radial artery.
- The patient suffered a stroke from the air embolism.
POTENTIAL FOR HARM: High
Emphasize the risk of catheter misconnections in orientation and training, and confirm during every procedure that the correct port is being used for an air injection.
Incorrect dialysate canister mix-up during hemodialysis therapy
CASE STUDY
- A patient was receiving hemodialysis (HD) therapy when it was noted:
- The citric acid disinfectant canister was erroneously connected to the dialysate line instead of the intended bicarbonate dialysate; and
- The bicarbonate dialysate was erroneously connected to the disinfectant solution canister instead of the citric acid disinfectant canister.
- The mix-up of these treatment canisters has the potential to result in electrolyte and/or acid-base imbalance, both of which may lead to serious patient injury or death.
- During treatment, the patient became unstable with low blood pressure and general distress. Despite discontinuing the treatment, the patient’s status deteriorated, and the patient died before the end of the treatment.
POTENTIAL FOR HARM: High
THE JOINT COMMISSION SAFETY TIP: To help prevent or minimize cross-connections or use of mismatched concentrates:
- Follow and conduct a safety check for every treatment, every time.
- Develop and use a system of labeling connector types and matching containers. This includes checking to make sure the proper connections of dialysates are completed prior to starting therapy.
- Measure conductivity and pH to ensure delivery of the proper composition of the dialysate.