Medical device manufacturer, Laerdal Medical, has issued a medical device safety alert concerning its Compact Suction Unit 4 (LCSU 4) [Catalogue Number: 880051, 880061, 881151, 880052, 880062 & 881152; Serial Number in the range 1808090001 to 2006060045 with Manufacturing Date (format YYYYMMDD) in the range 20180809 to 20200606; Affected Catalogue Number in Hong Kong: 880051, 880052, and 880061].

The service life of LCSU 4 units manufactured in the period 9 August 2018 to 6 June 2020 may be reduced due to weakness in the design and assembly process. The pump of the affected units may malfunction resulting in low suction levels or failure to provide suction.

Affected users can continue to use the affected units until received a replacement unit, but it is recommended to make note of the following safety measures recommended by the manufacturer:

• Follow local protocols for back-up suction devices. Do not repeatedly block the patient tube for more than 10 seconds at a time at vacuum levels greater than 300 mmHg.
• Only use canisters, tubes and accessories that are approved for the device by the manufacturer.
• When adjusting the vacuum level: When the desired vacuum level is reached; unblock the patient tube immediately.
• During patient treatment do not occlude or block the patient tube by intentional bending or squeezing. The patient tube should only be temporarily occluded by suctioning matter.
• When performing the Device Test: When the vacuum reaches minimum 500 mmHg immediately release the blocking.

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

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

Posted on 30 October 2020