Home› India› Ministry of Health and Family Welfare› Medical Device Alert date 21 July 2022...
Date: 2022-07-21 Category: Not Applicable State: Union Government Country: India

Medical Device Alert date 21 July 2022

Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

Research with AI Agent Chat with Document Generate Summary Translate Helpful Share Add to Project Create Task

Executive Summary & Key Takeaways

What it means

  • The Central Drugs Standard Control Organization (CDSCO) has issued a Medical Device Alert regarding an Urgent Medical Device Recall by Baxter Healthcare Corporation for Adsorba Hemoperfusion Cartridge 300 C and Adsorba 300 C due to the potential presence of particulate matter within the cartridge.
  • The alert provides background information on hemoperfusion and its uses, and highlights the potential health hazards associated with the particulate matter.

Key Changes

  • Baxter Healthcare Corporation is recalling specific lots of Adsorba Hemoperfusion Cartridge 300 C (Product code 101223, Lot nos. 1-419, 1-430, 1-439, 1-440, 1-441) and Adsorba 300 C (Product code 115264, Lot nos. 1-507, 1-508, 1-509, 1-512, 1-513, 1-514).
  • The recall is due to the potential presence of particulate matter within the cartridges.
  • The presence of particulate matter poses a health hazard, as it may reach the patient's vascular system and cause serious adverse health consequences if not detected before use.
  • The CDSCO has not received any complaints from the market regarding this issue.

Impact Analysis

Patients

  • Action Item: Healthcare providers should identify patients who have used the affected devices and monitor them for any potential adverse effects. They should also report any adverse events to the appropriate regulatory authorities.

Healthcare Providers

  • Action Item: Ensure that staff are trained on the recall and the potential risks associated with the affected devices.

Baxter India Pvt. Ltd.

  • Action Item: Investigate the root cause of the particulate matter contamination and implement corrective actions to prevent future occurrences.

CDSCO

  • Action Item: Continue to monitor the recall process and work with Baxter India Pvt. Ltd. to ensure its effectiveness. Communicate updates to healthcare providers and the public as needed.

Key Entities Referenced

Central Drugs Standard Control Organization (CDSCO): The national regulatory body for pharmaceuticals and medical devices in India. Baxter Healthcare Corporation: The manufacturer of the Adsorba Hemoperfusion Cartridge 300 C and Adsorba 300 C. Baxter India Pvt. Ltd.: The Indian subsidiary of Baxter Healthcare Corporation, responsible for the distribution and recall of the affected products in India. Adsorba Hemoperfusion Cartridge 300 C: A medical device used for hemoperfusion to remove certain drugs and toxins from the blood. Adsorba 300 C: A medical device used for hemoperfusion to remove certain drugs and toxins from the blood.
Official Source Record View Original Source →
See Full Document Text
Central Drugs Standard Control Organization Directorate General of Health Services Ministry of Health and Family Welfare Government of India (Medical Devices and Diagnostics Division) Email: ddcimd-cdsco@nic.in Food & Drugs Administration Bhawan, Kotla Road, New Delhi. F.No.29/Misc/03/2022-DC (192) Date: 21stJuly 2022 MEDICAL DEVICE ALERT DEVICE 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 ) BACKGROUND 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. Futher 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. Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the the Adsorba Hemoperfusion Cartridge 300 C and Adsorba 300 C due to the presence of particulate matter within the cartridge. Reason for Recall  There was recall due to the potential presence of particulate matter within the cartridge. Page 1 of 2Health Hazard  If particulate matter is not detected before use, the particles may reach the vascular system of the patient with potential serious adverse health consequences. Who May Be Affected  Any person with who have used an affected Adsorba Hemoperfusion Cartridge 300 C and Adsorba 300 C  Health care providers who treat people using the affected Adsorba Hemoperfusion Cartridge 300 C and Adsorba 300 C Note: CDSCO have not received any complaints from the market on this issue. FURTHER DETAILS & CONTACTS M/s Baxter India Pvt. Ltd, Gurgaon, Haryana had issued an Urgent Medical Device Recall which is attached herewith this alert. M/s Baxter India Pvt. Ltd. 5th Floor, Tower A Building 9, DLF phase III. DLF cyber city, Gurgaon 122002 Haryana, India India_product_complaints@baxter.com Tel +91-124-4500200 Fax +91-124-4500200 Page 2 of 2

Continue your research

Related Documents from Ministry of Health and Family Welfare