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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 004 12 14 000
Date submitted: 12/1/2014
Manufacturer:Unomedical A/S
Device Type:Infusion sets: Comfort, Comfort Short and Contact Detach, MiniMed Silhouette and MiniMed Sure-T infusion sets.
Description:Infusion pump
Medical Device Identifier:Affected Lot information is provided in the attached file.
Reason of Field Safety Corrective Action:tubing becoming detached at the connect/disconnect location on the infusion sets.
Remedy Action:Users are requested to do the following:

-When changing your infusion set, closely follow the instructions for use included in the product box. Check the tubing at the connect/disconnect location identified in the drawings above to make sure it is not loose.

-As always, it is essential to monitor your blood sugar levels frequently using your blood glucose meter. Proactively check your tubing connections occasionally throughout the day to ensure tubing is secure. It is especially important to check your blood sugar and tubing connections at bedtime to confirm insulin delivery is occurring.

-If you experience a high blood sugar, check your tubing connections and infusion site closely to ensure your tubing is secure.

If you discover the tubing is detached:
1. Do not attempt to reattach the tubing. Replace the infusion set immediately.
2. Treat any high blood sugar based on guidelines provided by your healthcare professional.
3. Call your distributor to report the issue. They will give you instructions on how to return the affected infusion set.
Athorized Representative/Importer/Distributor:Analysis Device For Medical and Scientific Service ( ADMSS )
Report Source:NCMDR
Source Ref. Number:A4A61EAE2923F
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Unomedical AS.pdf