CDSCO issues alerts against Adsorba Hemoperfusion Cartridge 300 C and Adsorba 300 C APAC due to the potential presence of particulate matter within the cartridge.
Baxter has issued a recall notice for various batches of Adsorba Hemoperfusion Cartridge 300 C and Adsorba 300 C APACdue to presence of particulate matter within the cartridge which may lead to serious adverse effects in the patients.
Hemoperfusion should be considered when a patient has taken life threatening amounts of adsorbable drugs, deep coma and one of symptoms are observed as hypoventilation, hypotonia, hypothermia, worsening of the clinical state despite conservative medical management; And if 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 drugs like 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. Furthermore 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 bloodstream for hemoperfusion treatment can be obtained by normal hemodialysis methods.
Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Adsorba Hemoperfusion Cartridge 300 C and Adsorba 300 C due to the presence of particulate matter within the cartridge.
CDSCO notified 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.
However, CDSCO has not received any complaints from the market on this issue.
