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 case

The California Department of Public Health (CDPH) recently issued a 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.

The error

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 potentially ensuing.

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.

Implementing improvements

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:

  1. Reviewed and readdressed education, including hands-on demonstrations, training, and routine competency reviews.
  2. Unsuccessfully sought a supplier of similar in-line suctioning without the cap in place.
  3. 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 T-Piece device.
  • A respiratory therapist should be present to initiate and closely monitor continuous flow therapy to the patient.

Addendum: Which devices have this cap?
Product Description Product Code
KIMVENT 10FR T-PIECE 21.3IN/54CM (black) 2105
KIMVENT 10FR T-PIECE 21.3IN/54CM (black) 8289
KIMVENT 12FR T-PIECE 12IN/30.5CM (white) 215135
KIMVENT 12FR T-PIECE 12IN/30.5CM (white) 21513511
KIMVENT Turbo-cleaning 12FR T-PIECE 12IN/30.5CM (white) 22715136
KIMVENT Turbo-cleaning 12FR T-PIECE 12IN/30.5CM (white) 227151236-5N
KIMVENT 12FR T-PIECE 21.3IN/54CM (white) 2155
KIMVENT 12FR T-PIECE 21.3IN/54CM (white) 215158
KIMVENT 12FR T-PIECE 22.2IN/56CM (white) 21559
KIMVENT 14FR T-PIECE 12IN/30.5CM (green) 220135
KIMVENT 14FR T-PIECE 12in/30.5CM (green) 8155
KIMVENT 14FR T-PIECE 12IN/30.5CM (green) 8251
KIMVENT 14FR T-PIECE 12IN/30.5CM (green) 2201358
KIMVENT 14FR T-PIECE 12IN/30.5CM (green) 8169
KIMVENT 14FR T-PIECE 12IN/30.5CM (green) 220123568
KIMVENT Turbo-cleaning 14FR T-PIECE 12IN/30.5CM (green) 227012358-5
KIMVENT Turbo-cleaning 14FR T-PIECE 12IN/30.5CM (green) 8308
KIMVENT Turbo-cleaning 14FR T-PIECE 12IN/30.5CM (green) 22701356
KIMVENT Turbo-cleaning 14FR T-PIECE 12IN/30.5CM (green) 2270123568-5N
KIMVENT 14FR T-PIECE 12IN/30.5CM (green) 22012356
KIMVENT 14FR T-PIECE 12IN/30.5CM (green) 22038040
KIMVENT 14FR T-PIECE 21.3IN/54CM (green) 2205
KIMVENT 14FR T-PIECE 21.3IN/54CM (green) 22056
KIMVENT 14FR T-PIECE 21.3IN/54CM (green) 2208A055
KIMVENT 14FR T-PIECE 21.3IN/54CM (green) 2208A005
KIMVENT 14FR T-PIECE 21.3IN/54CM (green) 2208A007
KIMVENT 14FR T-PIECE 21.3IN/54CM (green) 220125
KIMVENT 14FR T-PIECE 21.3IN/54CM (green) 2208A216
KIMVENT 14FR T-PIECE 21.3IN/54CM (green) 8248
KIMVENT 14FR T-PIECE 21.3IN/54CM (green) 8287
KIMVENT 14FR T-PIECE 21.3IN/54CM (green) 22058
KIMVENT 14FR T-PIECE 21.3IN/54CM (green) 2201258
KIMVENT 14FR T-PIECE 21.3IN/54CM (green) 22057
KIMVENT Turbo-cleaning 14FR T-PIECE 21.3IN/54CM (green) 2270125-5
KIMVENT Turbo-cleaning 14FR T-PIECE 21.3IN/54CM (green) 22701256-5N
KIMVENT Turbo-cleaning 14FR T-PIECE 21.3IN/54CM (green) 8309
KIMVENT Turbo-cleaning 14FR T-PIECE 21.3IN/54CM (green) 22701258-5
KIMVENT Turbo-cleaning 14FR T-PIECE 21.3IN/54CM (green) 227012586-5N
KIMVENT Turbo-cleaning 14FR T-PIECE 21.3IN/54CM (green) 2271457
KIMVENT 14FR T-PIECE 21.3IN/54CM (green) 220156
KIMVENT 14FR T-PIECE 21.3IN/54CM (green) 220256
KIMVENT 14FR T-PIECE 22.2IN/56CM (green) 22059
KIMVENT 14FR T-PIECE 22.2IN/56CM (green) 220569
KIMVENT 14FR T-PIECE 22.2IN/56CM (green) 220579
KIMVENT 14FR T-PIECE 22.2IN/56CM (green) 22015689
KIMVENT 16FR T-PIECE 21.3IN/54CM (orange) 2255
KIMVENT 16FR T-PIECE 21.3IN/54CM (orange) 22556
KIMVENT 16FR T-PIECE 21.3IN/54CM (orange) 225125-5NL
KIMVENT 16FR T-PIECE 21.3IN/54CM (orange) 225158
KIMVENT 16FR T-PIECE 22.2IN/56CM (orange) 22559
KIMVENT 18FR T-PIECE 21.3IN/54CM (red) 2305
KIMVENT 14FR T-PIECE 21.3IN/54CM (green) 220844
KIMVENT Turbo-cleaning 12FR T-PIECE 21.3IN/54CM (white) 2271516
KIMVENT Turbo-cleaning 14FR T-PIECE 21.3IN/54CM (green) 227056
KIMVENT Turbo-cleaning 16FR T-PIECE 21.3IN/54CM (orange) 2271656
KIMVENT Turbo-cleaning 10FR T 21.3IN/54CM (black) 227105
KIMVENT Turbo-cleaning 12FR T 12IN/30.5CM (white) 227135
KIMVENT Turbo-cleaning 12FR T 21.3IN/54CM (white) 22715
KIMVENT Turbo-cleaning 14FR T 12IN/30.5CM (green) 2270135
KIMVENT Turbo-cleaning 14FR T 21.3IN/54CM (green) 22705