Medical Dialogues
  • Dermatology
Login Register
This site is intended for healthcare professionals only
Login Register
  • MD Brand Connect
  • Vaccine Hub
  • MDTV
    • Breaking News
    • Medical News Today
    • Health News Today
    • Latest
    • Journal Club
    • Medico Legal Update
    • Latest Webinars
    • MD Shorts
    • Health Dialogues
  • Fact Check
  • Health Dialogues
Medical Dialogues
  • Medical News & Guidelines
      • Anesthesiology
      • Cardiology and CTVS
      • Critical Care
      • Dentistry
      • Dermatology
      • Diabetes and Endocrinology
      • ENT
      • Gastroenterology
      • Medicine
      • Nephrology
      • Neurology
      • Obstretics-Gynaecology
      • Oncology
      • Ophthalmology
      • Orthopaedics
      • Pediatrics-Neonatology
      • Psychiatry
      • Pulmonology
      • Radiology
      • Surgery
      • Urology
      • Laboratory Medicine
      • Diet
      • Nursing
      • Paramedical
      • Physiotherapy
  • Health news
      • Doctor News
      • Government Policies
      • Hospital & Diagnostics
      • International Health News
      • Medical Organization News
      • Medico Legal News
      • NBE News
      • NMC News
  • Fact Check
      • Bone Health Fact Check
      • Brain Health Fact Check
      • Cancer Related Fact Check
      • Child Care Fact Check
      • Dental and oral health fact check
      • Diabetes and metabolic health fact check
      • Diet and Nutrition Fact Check
      • Eye and ENT Care Fact Check
      • Fitness fact check
      • Gut health fact check
      • Heart health fact check
      • Kidney health fact check
      • Medical education fact check
      • Men's health fact check
      • Respiratory fact check
      • Skin and hair care fact check
      • Vaccine and Immunization fact check
      • Women's health fact check
  • AYUSH
    • Ayurveda
    • Homeopathy
    • Siddha
    • Unani
    • Yoga
  • State News
      • Andaman and Nicobar Islands
      • Andhra Pradesh
      • Arunachal Pradesh
      • Assam
      • Bihar
      • Chandigarh
      • Chattisgarh
      • Dadra and Nagar Haveli
      • Daman and Diu
      • Delhi
      • Goa
      • Gujarat
      • Haryana
      • Himachal Pradesh
      • Jammu & Kashmir
      • Jharkhand
      • Karnataka
      • Kerala
      • Ladakh
      • Lakshadweep
      • Madhya Pradesh
      • Maharashtra
      • Manipur
      • Meghalaya
      • Mizoram
      • Nagaland
      • Odisha
      • Puducherry
      • Punjab
      • Rajasthan
      • Sikkim
      • Tamil Nadu
      • Telangana
      • Tripura
      • Uttar Pradesh
      • Uttrakhand
      • West Bengal
  • Medical Education
      • Ayush Education News
      • Dentistry Education News
      • Medical Admission News
      • Medical Colleges News
      • Medical Courses News
      • Medical Universities News
      • Nursing education News
      • Paramedical Education News
      • Study Abroad
  • Industry
      • Health Investment News
      • Health Startup News
      • Medical Devices News
      • Pharma News
      • Pharmacy Education News
      • Industry Perspective
  • MDTV
      • Health Dialogues MDTV
      • Health News today MDTV
      • Latest Videos MDTV
      • Latest Webinars MDTV
      • MD shorts MDTV
      • Medical News Today MDTV
      • Medico Legal Update MDTV
      • Top Videos MDTV
      • Health Perspectives MDTV
      • Journal Club MDTV
      • Medical Dialogues Show
This site is intended for healthcare professionals only
LoginRegister
Medical Dialogues
LoginRegister
  • Home
  • Medical news & Guidelines
    • Anesthesiology
    • Cardiology and CTVS
    • Critical Care
    • Dentistry
    • Dermatology
    • Diabetes and Endocrinology
    • ENT
    • Gastroenterology
    • Medicine
    • Nephrology
    • Neurology
    • Obstretics-Gynaecology
    • Oncology
    • Ophthalmology
    • Orthopaedics
    • Pediatrics-Neonatology
    • Psychiatry
    • Pulmonology
    • Radiology
    • Surgery
    • Urology
    • Laboratory Medicine
    • Diet
    • Nursing
    • Paramedical
    • Physiotherapy
  • Health news
    • Doctor News
    • Government Policies
    • Hospital & Diagnostics
    • International Health News
    • Medical Organization News
    • Medico Legal News
    • NBE News
    • NMC News
  • Fact Check
    • Bone Health Fact Check
    • Brain Health Fact Check
    • Cancer Related Fact Check
    • Child Care Fact Check
    • Dental and oral health fact check
    • Diabetes and metabolic health fact check
    • Diet and Nutrition Fact Check
    • Eye and ENT Care Fact Check
    • Fitness fact check
    • Gut health fact check
    • Heart health fact check
    • Kidney health fact check
    • Medical education fact check
    • Men's health fact check
    • Respiratory fact check
    • Skin and hair care fact check
    • Vaccine and Immunization fact check
    • Women's health fact check
  • AYUSH
    • Ayurveda
      • Ayurveda Giuidelines
      • Ayurveda News
    • Homeopathy
      • Homeopathy Guidelines
      • Homeopathy News
    • Siddha
      • Siddha Guidelines
      • Siddha News
    • Unani
      • Unani Guidelines
      • Unani News
    • Yoga
      • Yoga Guidelines
      • Yoga News
  • State News
    • Andaman and Nicobar Islands
    • Andhra Pradesh
    • Arunachal Pradesh
    • Assam
    • Bihar
    • Chandigarh
    • Chattisgarh
    • Dadra and Nagar Haveli
    • Daman and Diu
    • Delhi
    • Goa
    • Gujarat
    • Haryana
    • Himachal Pradesh
    • Jammu & Kashmir
    • Jharkhand
    • Karnataka
    • Kerala
    • Ladakh
    • Lakshadweep
    • Madhya Pradesh
    • Maharashtra
    • Manipur
    • Meghalaya
    • Mizoram
    • Nagaland
    • Odisha
    • Puducherry
    • Punjab
    • Rajasthan
    • Sikkim
    • Tamil Nadu
    • Telangana
    • Tripura
    • Uttar Pradesh
    • Uttrakhand
    • West Bengal
  • Medical Education
    • Ayush Education News
    • Dentistry Education News
    • Medical Admission News
    • Medical Colleges News
    • Medical Courses News
    • Medical Universities News
    • Nursing education News
    • Paramedical Education News
    • Study Abroad
  • Industry
    • Health Investment News
    • Health Startup News
    • Medical Devices News
    • Pharma News
      • CDSCO (Central Drugs Standard Control Organisation) News
    • Pharmacy Education News
    • Industry Perspective
  • Home
  • News
  • Industry
  • Pharma News
  • CDSCO issues alert on...

CDSCO issues alert on Baxter Blood Purification Device Hemoperfusion Cartridge

Dr. Divya ColinWritten by Dr. Divya Colin Published On 2022-07-30T18:00:23+05:30  |  Updated On 30 July 2022 6:00 PM IST
CDSCO issues alert on Baxter Blood Purification Device Hemoperfusion Cartridge
  • facebook
  • twitter
  • linkedin
  • whatsapp
  • Telegram
  • Email

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 Adsorba Hemoperfusion Cartridge 300 C and Adsorba 300 C due to the presence of particulate matter within the cartridge.

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.

Regarding the need of hemoperfusion, the Medical device alert stated that Hemoperfusion should be considered if:

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.

Also Read:No relief to Medical Device makers: Health Minister declines to relax deadline for registration of medical devices

baxterblood purification systemCartridgecdscomedical device alert
Dr. Divya Colin
Dr. Divya Colin

    Doctor of Pharmacy

    Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

    Show Full Article
    Next Story

    Editorial

    Featured image representing medico legal

    What's the Role of Expert Opinion in Medical Negligence?

    7- Point Discharge Protocol for AECOPD: Time to Inculcate in Practice

    7- Point Discharge Protocol for AECOPD: Time to Inculcate in Practice

    Aspirin Use in Women Aged 40-50 with Diabetes and Hypertension: Identifying the Ideal Candidates

    Aspirin Use in Women Aged 40-50 with Diabetes and Hypertension: Identifying the Ideal Candidates

    Darbapoetin Alfa In Chemotherapy Induced Anaemia: Check out 5 takeaways from recent study

    Darbapoetin Alfa In Chemotherapy Induced Anaemia: Check out 5 takeaways from recent study

    Biosimilar Denosumab of Alkem (Denuril) shows Comparable Efficacy in Treating Postmenopausal Osteoporosis in Indian Women

    Biosimilar Denosumab of Alkem (Denuril) shows Comparable Efficacy in Treating Postmenopausal...

    View All

    Journal Club Today

    Medical Journalism: Need of the Hour - Ft: Dr Prem Aggarwal (Chairman, Medical Dialogues), Dr Nandita Mohan (Head, MDTV Division, Medical Dialogues)

    Medical Journalism: Need of the Hour - Ft: Dr Prem Aggarwal (Chairman, Medical Dialogues), Dr...

    View All

    Health News Today

    Health Bulletin 08/ May/ 2025

    Health Bulletin 08/ May/ 2025

    View All
    © 2022 All Rights Reserved.
    Powered By: Hocalwire
    X
    We use cookies for analytics, advertising and to improve our site. You agree to our use of cookies by continuing to use our site. To know more, see our Cookie Policy and Cookie Settings.Ok