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BLOOD CULTURE BacT/ALERT Paed (PF Plus), bot. [BMX-410853]

https://unicat.msf.org/cat/product/68047
STD SBCMRDTUBAPPF

Valid Article

Former Code(s): SLASZFR0509 SLASAURAP5B- SLASAURAP5B ELAEMDSC001
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).
Article is intended to be used with children (<12 years) ONLY.
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.
12
Shelf life = length of time a product can remain active and effective. Short shelf life = shelf life = < 24 months
W0104010504 - Bottles for automated blood culture
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.
P
The order of this product needs to be justified and is only acceptable under certain conditions.
1525
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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BacT/ALERT PF Plus, Pediatric (automatic)

CAUTION

This test is worded and codified by unit to make the order easier, but it is always packaged in kit of 100.

Definition

BacT/ALERT® PF Plus Culture Bottles are used with the BacT/ALERT® Microbial Detection System in qualitative procedures for recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast) from blood for pediatric patients.

Specifications

BACT/ALERT® Microbial Detection Systems utilize a colorimetric sensor and reflected light to monitor the presence and production of carbon dioxide (CO2) dissolved in the culture medium.

If microorganisms are present in the test sample, carbon dioxide is produced as the organisms metabolize the substrates in the culture medium. When growth of the microorganisms produces CO2, the color of the gas-permeable sensor installed in the bottom of each culture bottle changes from blue-green to yellow. The lighter color results in an increase of reflectance units monitored by the system. Bottle reflectance is monitored and recorded by the instrument every 10 minutes.

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Components

Each bottle contains 30 mL of complex medium and ≥1.6 g adsorbent polymeric beads.

At time of manufacture, the medium consists of the following reactive components:

  • combination of peptones/biological extracts (≥1.85% w/v),
  • anticoagulant (≥0.083% w/v),
  • vitamins and amino acids (≥0.00145% w/v)
  • carbon sources (≥0.45% w/v),
  • trace elements (≥0.0005% w/v).

Bottles contain an atmosphere of N2, O2, and CO2, under vacuum.

Technical specifications

  • BACT/ALERT® culture bottles contain polycarbonate. Not all disinfectants are intended for use with polycarbonate surfaces and may cause bottle deterioration.
  • Volume of blood to be added: 4 ml
  • Colour-coded: yellow

Packaging & Labelling

Kit composed of 100 culture bottles containing 30 ml of culture medium each.

To be Ordered Separately

  • BACT/ALERT® Microbial Detection Systems
  • Blood-drawing device
  • Blood Collection Adapter Cap
  • Sterile Airway Needle/Subculture Units
  • Disposable gloves
  • Appropriate biohazard waste containers for materials potentially contaminated with infectious agents
  • Alcohol pads or equivalent

Instructions for use

  • Follow the recommendations of the package insert.
  • If the bottles are exposed to temperatures less than 15°C, precipitates may form that will disappear when the bottles are warmed to room temperature.
  • Bottles must be at room temperature before use.

Please consult the “Bacteriology laboratory procedures and resources” available online via the Laboratory working Group sharepoint page: Laboratory Procedures and Resources

https://msfintl.sharepoint.com/sites/msfintlcommunities/LabWG/SitePages/Bacteriology-Laboratory-Resources.aspx

For offline access, contact your laboratory advisor

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Precautions for Use

All biological samples must be considered as potentially infectious and handled with the usual precautions (compulsory wearing of gloves, hand washing, etc.).

Storage

  • BacT/ALERT PF Plus Culture Bottles are ready for use.
  • Store in an upright position.
  • Store at room temperature (15°C-30°C).
  • Store protected from direct sun light.
  • Do not use after expiration date.
  • Shelf life : 12 months.
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of the total shelf life

Waste management

After use, sterilize the cultures and all contaminated material. Please contact your watsan referent for advice on proper disposal.

MSF requirements

Reserved for bacteriology programmes.

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