CDSCO issues alert on Baxters blood purification device hemoperfusion cartridge

New Delhi, July 28, 2022:

The Central Drugs Standard Control Organisation (CDSCO) has issued a medical devices alert on Baxter Healthcare’s Absorba Hemoperfusion Cartridge 300 C and Absorba 300 C, devices used in blood purification, due to presence of particulate matter within the cartridge.

Baxter has informed the CDSCO that it “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”. If the particulate matter is not detected before use, the particles may reach the vascular system of the patient with potential serious adverse health consequence, it added.

However, there have been no complaints or patient injury associated with this issue, said the company in a regulatory filing. The company has also released the batches/lots which were affected, with expiration date ranging between February and October, 2024.

Hemoperfusion is to complement existing blood purification technologies, if the patient has taken life threatening amounts of adsorbable drugs, or is in a deep coma and symptoms such as hypo ventilation, hypotonia, hypothermia, worsening of the clinical state despite conservative medical management, among others.

If the patient has taken drugs of which the amount, composition and kind are unknown and the patient is deeply comatose, hemoperfusion can be considered. The Adsorba has been proven a high degree of efficacy for the drugs including barbiturates, organophosphates, bromo carbamide, paracetamol, ethchlorvynol, paraquat, meprobamate, salicylate, among others.

The use of hemoperfusion as a supplementary treatment does not mean that other conventional methods of treatment should be omitted. Measures such as gastric lovage, establishment of free airway and assisted respiration, controlled electrolyte and water balance, and forced dieresis 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 blood stream for hemoperfusion treatment can be obtained by normal hemodialysis methods.

The company said that any person who has used an affected Adsorba Hemoperfusion Catrdige 300C and Adsorba 300 C, may be affected. CDSCO has said that it has not received any complaints from the market on this issue.

Baxter has sought the customers to return the product to the company directly, if purchased directly from the company, by completing the customer reply form and sending it through email to Baxter. If it has been purchased form a distributor, the company advises the customers to contact the distributor for return and credit. Pharmabiz