|DRAP Alert No||No I/V/05-23-23|
|Action Date||17th May 2023|
|Target Audience||-Healthcare Professionals particularly working in the critical care areas of hospitals including Physicians, Pharmacists, and Nurses.|
-Procurement Officers at Hospitals and Healthcare Institutions,
-Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
|Product(s) Affected||AQUAVENT NEO Neonatal CPAP limb|
(Ventilator breathing circuit)
Manufactured by: Armstrong Medical Limited, Northern Ireland, Distributed by M/s. Elate C.C (Pvt) Ltd. Karachi, Pakistan
Batch No. 230123 (230123 as per the list in the Field Safety Notice)
|Problem / Issue||Armstrong Medical Limited, Ireland received reports for their Neonatal Breathing Circuits for risk of patient harm as a result of tubing (and a connector attached to the tubing) disconnecting from the elbow within Neonatal Breathing Circuits. Accordingly, the manufacturing company has issued a field safety notice and initiated recall of the defective product from the international market including Pakistan.|
|Action Initiated||-The manufacturing company has initiated a recall of the affected lots of defective products from the market where it was distributed. |
-All healthcare professionals working in critical care units of hospitals as well as pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these lots of the product. The remaining stock should be quarantined and returned to the supplier/company.
-Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or through phone at +92 51 910 73 17, or by Email at gsms∂dra.gov.pk.
-Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
|Advice for Healthcare Professionals||-DRAP requests increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return this product’s defective batch(es) to the importer/company. |
-Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using Adverse Event Reporting Form or online through this link.
-Please click here for further information on problem reporting to DRAP.
|Advice for Consumers||-Consumers should stop using this product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this Medical Device.|
-All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.