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BALLOON + CATHETER, POST-PARTUM HAEMORRHAGE, 500 ml

https://medicalguidelines.msf.org/en/node/8-2-early-postpartum-haemorrhage-51417782.html#id-.8.2Earlypostpartumhaemorrhagevenglish-8.2.4Managementofpersistenthaemorrhage
https://unicat.msf.org/cat/product/18275
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Former Code(s): -X
The product is supplied (and stored) sterile, it must remain sterile until its use. Sterile = state of being free from all living microorganisms.
Single use
A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
U100102 - Postpartum intrauterine catheters
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
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In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
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The product is part of at least one Kit. A kit is a collection of products (medical and/or logistic) that are needed for a certain intervention in emergency. The choice and quantity of the articles reflects the MSF protocols for this specific situation. The use of Kits allows to start an intervention without a detailed evaluation.
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BALLOON CATHETER POST-PARTUM HAEMORRHAGE

Definition

The Intrauterine haemostatic balloon catheter consists of a silicone dual lumen catheter with an inflatable silicone tamponade balloon attached on the distal end. One lumen of the catheter serves as the conduit through which saline is infused into the balloon after insertion into the bleeding uterus. When inflated properly to press against the uterine wall, the balloon provides compression against multiple sites of torn arteries, lacerations and other tissue evoking haemorrhage. The second lumen, which is open at the distal end of the catheter, provides a drainage port for blood and other bodily fluids. At the proximal end of the catheter, a stopcock retains the saline in the balloon until a clinician gradually drains it allowing the uterus to contract.

Specifications

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Technical specifications

  • Silicone catheter and balloon (latexfree)
  • Balloon:
    • Volume: 500 ml
  • Catheter
    • Main channel with open bevelled distal end: allows direct measuring of blood loss
    • Separate lumen to inflate the balloon and with a Luer connector at its proximal end which connects to the syringe
    • diameter: CH 24
    • length: +/- 54 cm
  • Rapid instillation component
  • Syringe 60 ml
  • Sterile, for single use

Packaging & Labelling

Each unit is individually packaged in sterile peel-open pack

(Cf Introduction: Packaging and labelling)

Instructions for use

See the enclosed users' guide.

The balloon can be inflated directly with the enclosed syringe or through the rapid instillation component.

Always inflate the balloon with sterile liquid (e.g. normal saline), never with air or any other gas.

Rapid instillation component allows the connection of 3 different parts: balloon, bag with sterile liquid and enclosed syringe. The system is designed so the sterile liquid goes from the drip to the syringe when pulling the plunger, and into the balloon catheter when pushing it.

Image

Precautions for Use

Patient monitoring is an integral part of managing postpartum hemorrhage. Signs of deterioration or non-improvement in the patient's condition should lead to a more aggressive treatment and management of patient uterine bleeding.

Patient urine output should be monitored while the Postpartum Balloon is in use.

MSF requirements

A life saving, easy to use tamponade technique for the management of postpartum haemorrhage that should be present in every maternity

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