Laerdal Suction Units (LSUs) powered by LSU Nickel Metal Hydride (NiMH) Batteries [Consumable]
Bound Tree Item Nos.: L780020, 2223-80078, 4650-LMCLSU-R; LSU Catalog No. 78002001; NiMH Battery Catalog No. 780800; Battery Serial Nos.: 78451361071 and above
All LSU lot numbers distributed between December 9, 2013, and July 26, 2016; All battery lot numbers distributed beginning December 9, 2013
In a July 15, 2016, Urgent Field Safety Notice letter posted by the German Federal Institute for Drugs and Medical Devices (BfArM) and an August 15, 2016, Urgent Medical Device Correction letter submitted by an ECRI Institute member hospital, Laerdal states that a problem that may occur while the above LSUs are used with the above batteries when the battery has been stored or installed at temperatures between 0°C and 9°C. Following storage at temperatures between 0°C and 9°C (32°F and 48°F), the LSU with NiMH battery may shut off after a few seconds when operating at a vacuum level greater than 200 mmHg when set to either the 350 mmHg or 500+ mmHg (46.6 kPa or 66.5+ kPa) dial setting. Laerdal states that this can occur if the LSU is installed in an ambulance parked outside in very cold climates, without heating in the vehicle. It can also occur if the NiMH battery is stored at low temperatures and installed in the LSU immediately before use. Laerdal further states that when the core temperature of the NiMH battery is low and the suction tube is occluded, the ability of the battery to supply power to the LSU at high vacuum settings (350 mmHg or 500+ mmHg, 46.6 kPa or 66.5+ kPa) may be impaired. This may happen because the voltage in the battery drops when the suction tube is occluded to a level where the LSU unit is programmed to shut down. This can occur when performing suction, or when the device test or battery quality tests described in the Directions for Use (DFU) are being performed. If the LSU shuts off, the unit will not provide suctioning. This may cause a delay in clearing of the patient’s airways. The manufacturer has not confirmed the information provided in the source material.
Identify any affected product in your inventory. If you have affected product, verify that you have received the August 25, 2016, letter, copy of the Laerdal July 15, 2016, Urgent Field Safety Notice letter and August 15, 2016, Urgent Medical Device Correction letter and Customer Acknowledgment Form (U.S. customers) from Bound Tree. Review the Laerdal letter and the addendum to the directions for use. The following actions are those listed in Alert Accession No. A26974. Laerdal recommends that you review your present emergency operating procedures and check any backup equipment to support a rapid and appropriate response to any unexpected equipment failure. If the problem occurs, the short-term or interim solution to restore LSU operation is to switch the unit to 0 (off) then back to a reduced suction level (refer to attachments to the letter). Inform all relevant personnel of the storage temperature problem potential and the interim instructions in the "Addendum to Direction for Use" included with the letter. Keep a copy of the letter with your LSU DFU booklet. Complete the Customer Acknowledgement Form, and return it to Stericycle using the instructions on the form. Laerdal will use the information on the form to contact your facility when a long-term solution becomes available.
For Further Information:
Laerdal customer solution center
Tel.: (877) 523-7325