New Delhi: In suspecting the presence of particulate matter, Central Drug Standard Control Organization (CDSCO) has issued medical devices alert on Baxter Healthcare's Adsorba Hemoperfusion Cartridge 300 C and Adsorba 300 C which are the devices used in blood purification.This came followed by an Urgent Medical Device Recall issued by Baxter Healthcare Corporation for the the...

New Delhi: In suspecting the presence of particulate matter, Central Drug Standard Control Organization (CDSCO) has issued medical devices alert on Baxter Healthcare's Adsorba Hemoperfusion Cartridge 300 C and Adsorba 300 C which are the devices used in blood purification.

The recalled products include Adsorba Hemoperfusion Cartridge 300 C (Product code – 101223, Lot no. 1-419, 1-430, 1-439, 1-440, 1-441) and Adsorba 300 C (Product code – 115264, Lot no. 1-507,1-508, 1-509, 1-512, 1-513, 1-514).

The Adsorba 300C hemoperfusion cartridge is a steam sterilized device which contains 300 grams of cellulose-coated activated charcoal. The device is filled with physiological saline solution prior to sterilization.

ADSORBA is used for the removal of toxins from a patient's blood, and that holds materials (e.g., activated carbon or resins) which absorb (adsorb) a specific toxin or range of toxins. Hemoperfusion is used when the patient requires immediate elimination of toxic substances to maintain his life.

Hemoperfusion is the process whereby blood is passed through a sorbent system to remove specific toxic substances in the blood. The sorbent system is made up of a plastic housing, or cartridge, which contains the granules that allow adsorption of molecules.

1. After taking life threatening amounts of adsorbable drugs, deep coma and one of the following symptoms are observed: hypoventilation, hypotonia, hypothermia, worsening of the clinical state despite conservative medical management;

2. The patient has taken drugs of which the amount, composition and kind are unknown and the patient is deeply comatose.

The Adsorba has proven a high degree of efficacy for the following drugs: barbiturates, organophosphates, bromocarbamide, paracetamol, ethchlorvynol, paraquat, meprobamate, phenacetin, methaqualone, salicylate.

"The use of hemoperfusion as a supplementary treatment does not mean that other conventional methods of treatment should be omitted; measures such as gastric lavage, establishment of free airway and assisted respiration, controlled electrolyte and water balance, and forced diuresis should be administered whenever indicated. Further more it might be necessary to monitor carefully the blood levels of vital substances or drugs which also could be adsorbed during the hemoperfusion treatment. Access to the blood stream for hemoperfusion treatment can be obtained by normal hemodialysis methods.", the notice further added.

The notice highlighted the cause of the recall, stating that there was a recall because there may have been particulates inside the cartridge.

Furthermore, the notice added that If particulate matter is not detected before use, the particles may reach the vascular system of the patient with potential serious adverse health consequences.

Additionally, the alert addressed Who May Be Affected by saying,

i) Any person with who have used an affected Adsorba Hemoperfusion Cartridge 300 C and Adsorba 300 C

ii) Health care providers who treat people using the affected Adsorba Hemoperfusion Cartridge 300 C and Adsorba 300 C."

However, CDSCO stated that it had not heard from the market regarding any complaints regarding this matter.

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