Alert—KimVent® Closed Suction System (Adults) T-Piece February 28, 2012
The cap needs to be removed for safe use in patients receiving
continuous flow therapy.
CHPSO periodically reviews California Department of Public Health
(CDPH) citations for opportunities to improve patient safety and
prevent future events.In reviewing the following event, CHPSO
identified a recurrent issue (as evidenced by reports in the FDA
device event database).
The California Department of Public Health (CDPH) recently issued
citation and fine for a patient death resulting from an error
in use of the KimVent® Closed Suction System (Adults) with
integral T-Piece. In this case, a nurse went to change the device
that was attached to the patient’s tracheostomy. According to the
CDPH report, the patient “was breathing humidified air and
oxygen through this T-piece on her own. When the T-piece comes in
the package for changing it comes with a cap on the expiration
port. The cap must be removed prior to use when the patient is
breathing on her own. Essentially, LVN 1 did everything right
except she left the cap on. She said she took the cap off. When
another nurse (LVN 2) came in to check on Patient A, she saw the
cap was on the T-piece expiration port and the patient was not
breathing on her own.” The patient died.
Review of adverse event reports from the FDA Manufacturer and
User Facility Device Experience (MAUDE)
database shows at least five medical device adverse event reports
(MDRs) that occurred between February 2009 to present involving
three deaths and a number of serious complications arising from
the same type of error as in this case.
This particular device includes an integral capped T-piece (see
illustration), allowing it to be used in either mechanically
ventilated patients or patients spontaneously breathing from a
continuous flow (e.g., humidified air). With a mechanical
ventilator, gases flow back and forth through the side port of
the device. However, with continuous flow, gases flow in through
the side port and must be exhausted to the atmosphere through the
other side port (shown atop of the T-piece in figure). Thus the
T-piece cap must be removed for safe use with continuous flow.
Failure to remove the cap will result in increasing airway
pressure, with pneumothorax, hypotension and cardiac arrest
Because the packaged device has the cap in place to provide a
sterile closed airflow path, caregivers must remember to remove
the cap when appropriate. The device itself has no
characteristics that assist in remembering this step (e.g., color
coding). Errors with this device are rare. Nevertheless, since
error, if undetected, can be catastrophic, steps to reduce the
risk of error are in order.
To quote To Err is Human: “Safety does not reside in a person,
device or department, but emerges from the interactions of
components of a system.” The provider can address the person, but
to address the device factors, a provider has either to change
purchasing patterns or seek change from the device manufacturer.
According to the report, the provider did the following to
address the equipment safety issue:
Reviewed and readdressed education, including hands-on
demonstrations, training, and routine competency reviews.
Unsuccessfully sought a supplier of similar in-line
suctioning without the cap in place.
Assured familiarity with the patient by making the nurse
caring for the patient responsible for the tubing change.
CHPSO noted the inability to find a supplier of a similar device
without a cap and contacted Kimberly-Clark to see if changes can
be made to the device or its packaging. We thank Kimberly-Clark
for their attention to this issue. Their response follows:
Manufacturer’s comments and advice
Kimberly-Clark Health Care takes every adverse event seriously
and is reviewing potential changes to the KimVent® Closed Suction
System (Adults) T-Piece to further reduce the risk of user error.
The T-Piece cap must be removed when appropriate. This step is
specifically needed when the clinician is initiating continuous
flow therapy. This step is also needed when applying this device
to a patient already on continuous flow therapy.
The same T-Piece design has been in the market since 1985, with
an estimated 100 million closed suction products having been
distributed and with very low complaint rates attributable to
user error because of a failure to remove the T-piece cap during
continuous flow therapy. While this failure mode has been rare,
when it happens it can unfortunately lead to potentially serious
injury or death if not detected by the clinician monitoring the
patient continuous flow therapy. Currently, each individual
KimVent® Closed Suction System with T-Piece device label cautions
the user to consult the Directions for Use prior to use. The
Directions for Use for the device contains the following patient
safety Warning in bold print:
Warning: Cap on KimVent® T-Piece prevents continuous flow
therapy. Remove cap before starting continuous flow therapy.
Failure to remove cap prior to continuous flow therapy may result
in serious injury or death.
We are consistently evaluating potential changes to device
labeling and/or packaging that may further reduce the occurrence
of all user errors, if possible. Some of the changes we are
evaluating with regard to this T-Piece product are:
Change the color of the T-Piece cap to red to further
identify the cap.
Print the international “read Directions For Use” symbol on
the cap (i.e., the triangle with exclamation point in it) to
again alert the user to read the Directions for Use prior to use.
Evaluate existing Directions for Use for opportunities to
further reinforce the need for T-Piece Cap removal during
continuous flow therapy
We advise the following to minimize the risk of error:
As with any medical device that is used during a high risk
(or critical) procedure, review the device Directions for Use
with special emphasis on the device Warnings and Cautions.
Clinicians should be current on training required for
continuous flow therapy with the KimVent® Closed Suction System
A respiratory therapist should be present to initiate and
closely monitor continuous flow therapy to the patient.