Safety Alerts

Medical device manufacturer, Baxter Healthcare Ltd, issued a medical device safety alert concerning its Transfer Set (MiniCap Extended Life PD Transfer Set (6") with Twist Clamp) [Product Code: 5C4482; Lot Numbers: All lots within expiry] [HKMD No.: 140102].

The manufacturer is advising users that certain cleaning products and solvents may cause damage (for example, leaking or cracking), if they come into direct contact with the transfer set:

• Cleaning products such as hand sanitizer, or those containing, but not limited to, hydrogen peroxide, bleach, alcohol or antiseptic agents
• Solvents intended to remove adhesive residue, such as those containing acetone, toluene, xylene, or cyclohexanone

According to the manufacturer, a damaged or leaking transfer set could result in microbial contamination of the sterile fluid path. This may predispose patients to peritonitis. Additional hazards that may result include delay in therapy and exposure to bodily fluids.

The manufacturer will be updating the Instructions for Use (IFU) to include a warning against the use of these cleaning products and solvents.

The manufacturer is instructing affected users to take the following actions:

• If affected users are using one of the above-mentioned cleaning products or solvents, they should discontinue use of this product or solvent immediately. Affected users should ensure all home patients are aware of proper cleaning practices. Clinicians who are not using any of the above-mentioned cleaning products or solvents may continue to use Baxter transfer sets.
• If a patient is using one of the incompatible cleaning products or solvents to clean a transfer set, they should discontinue use of the cleaning product or solvent immediately and inspect their transfer set for signs of leakage or cracks. If this type of damage is identified, affected users should replace their transfer set and contact Baxter.
• The transfer set during use is not considered a sterile product and does not need to be regularly cleaned. Risk of contamination only comes through a breach in the fluid path. The Minicap 6AC4466H (not part of this medical device safety alert) can be used to disinfect the tip and front threads of the transfer set which do not need to be cleaned. If the main body (light blue part) needs to be cleaned, mild soap and water are considered suitable options.

According to the local supplier, the affected devices are distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 18 Jan 2022