Illustrations for placing the Bakri balloon (step 3)

Bakri ®

P O S T PA R T U M B A L L O O N W I T H R A P I D I N S T I L L AT I O N C O M P O N E N T S

Tamponade technique
for postpartum hemorrhage
Refer to the Instructions for Use for complete information on product usage and a
Fig. 1: Transvaginal placement, postvaginal delivery
­complete list of precautions, warnings, and contraindications.

1 Confirm before placement.

Confirm that these statements are true:
• The uterus is free of placental fragments.
• The genital tract has no trauma or lacerations.
• The source of the bleeding is not arterial.
• The patient does not present with any contraindications for use of this device.

2
Determine the uterine cavity’s volume.
• For transvaginal placement, determine uterine volume by direct
examination or ultrasound examination. For transabdominal placement, Fig. 2: Transabdominal placement, postcesarean delivery
determine uterine volume by direct examination.
• Place the predetermined volume of sterile fluid in a separate container.
• If you will use the rapid instillation components, note the predetermined Proper placement
volume for rapid instillation.
• The maximum balloon volume is 500 mL.

Illustration A and B by Lisa Clark

3 Place the balloon.
Transvaginal placement, postvaginal delivery (Fig. 1)
• Insert the balloon portion of the catheter into the uterus, making certain that
the entire balloon is inserted past the cervical canal and internal ostium.
Transabdominal placement, postcesarean delivery (Fig. 2)
• Pass the uninflated balloon, inflation port first, through the cesarean incision
and into the uterus and cervix. Remove the stopcock to aid in placement and A B
reattach it prior to filling the balloon.
• Have an assistant pull the balloon shaft through the vaginal canal until the • Make sure that the entire • If necessary, pack the
base of the balloon contacts the internal cervical ostium. balloon is inserted past vagina with iodine- or
• Close the incision, being careful not to puncture the uninflated balloon the cervical canal and antibiotic-soaked gauze.
while suturing. internal ostium. • Do not extend the
• After the balloon packing into the uterus.

4
is inflated to the
Fill the balloon with sterile liquid. predetermined volume,
use ultrasound to confirm
• Never inflate the balloon with air, carbon dioxide, or any other gas. that it is properly placed.
• Do not fill with more than 500 mL. Overinflation may result in the balloon
being displaced into the vagina.
• Ensure that all product components are intact and that the hysterotomy is CONTRAINDICATIONS
securely sutured prior to balloon inflation. • Arterial bleeding requiring surgical exploration or angiographic
embolization
• Place a Foley catheter in the patient’s bladder to collect urine and monitor • Cases indicating hysterectomy
urine output.
• Pregnancy
• Use the enclosed syringe or rapid instillation components to fill the
balloon to the predetermined volume through the stopcock. • Cervical cancer
• If desired, apply traction to the balloon’s shaft. In order to maintain tension, • Purulent infections in the vagina, cervix, or uterus
secure the balloon shaft to the patient’s leg or attach to a weight, not to • Untreated uterine anomaly
exceed 500 grams. Note: To prevent displacement of the balloon into the
• Disseminated intravascular coagulation
vagina, counterpressure can be applied by packing the vaginal canal with
iodine- or antibiotic-soaked gauze. • A surgical site that would prohibit the device from effectively controlling
• Use ultrasound to confirm that the balloon is properly placed. bleeding
WARNINGS

5
Flush the lumen and monitor hemostasis. • This device is intended as a temporary means of establishing hemostasis in
cases indicating conservative management of postpartum uterine bleeding.
• Connect the drainage port to a fluid collection bag to monitor hemostasis. • The Bakri Postpartum Balloon is indicated for use in the event of primary
• The balloon drainage port and tubing may be flushed clear of clots with postpartum hemorrhage within 24 hours of delivery.
sterile isotonic saline to facilitate monitoring.
• The device should not be left indwelling for more than 24 hours.
• Monitor the patient for signs of increased bleeding and uterine cramping.
• The balloon should be inflated with a sterile liquid such as sterile water,

6
sterile saline, or lactated Ringer’s solution. The balloon should never be
Remove the balloon. inflated with air, carbon dioxide, or any other gas.
• The maximum inflation is 500 mL. Do not overinflate the balloon. Overinfla-
• Maximum indwelling time: 24 hours. tion of the balloon may result in the balloon being displaced into the vagina.
• The attending clinician determines when the balloon is removed after
• Patients in whom this device is being used should be closely monitored for
bleeding is controlled and the patient is stable.
signs of worsening bleeding and/or disseminated intravascular coagulation
(DIC). In such cases, emergency intervention per hospital protocol should
• Release the tension on the shaft and remove any vaginal packing. be followed.
• Aspirate balloon contents until the balloon is completely empty. The fluid
• There are no clinical data to support the use of this device in the presence
may be removed incrementally to allow for periodic observation of the
of DIC.
patient. In an emergency, the shaft may be cut to rapidly deflate the balloon.
• Gently retract the balloon and discard it. • Patient monitoring is an integral part of managing postpartum hemorrhage.
• Monitor the patient for signs of bleeding. Signs of a deteriorating or unimproving condition should lead to a more
aggressive treatment and management of the patient’s uterine bleeding.
• The patient’s urine output should be monitored while the Bakri Postpartum
Balloon is in use.
PRECAUTIONS
• Avoid excessive force when inserting the balloon into the uterus.
MEDICAL
• This product is intended for use by physicians trained and experienced in
obstetrics and gynecological techniques.
Bakri ®

P O S T PA R T U M B A L L O O N W I T H R A P I D I N S T I L L AT I O N C O M P O N E N T S

How to use the rapid instillation components

1 2

3 4

10

30
5 6
10

2200
10

30
20

40
30

50
40

60
50

60

MEDICAL
cookmedical.com

© COOK 11/2017  RH-D38426-EN-F