Generic Name: Infusion Pump For Pain-free Patient Management — Trade Name: Terfusion Compact Syringe Pump Te-362

Recalling firm: Name of Manufacturer and Distributor: Terumo Corporation — Address of Manufacturer and Distributor: 2-44-1 Hatagaya, Shibuya-ku, Tokyo — Type of License: Class I Medical Device Manufacturer and...
Product: Lot: 製品コード：TE-362PCA ロット：初回出荷以降の全ロット 210901/211001/211101/211201/220101/220201/220301/220401/220501/220601/220701/220801/220901/221001/22 1101/221201/230101/230201/230301/230401/230501/230601/230701/230801/230901/231001/231101/231201/2401 01/240201/240301/240401/240501 出荷数量：3029台（＊＊）出荷時期：令和3年10月6日〜令和6年6月7日(＊). Use: 本品はシリンジ内の薬液を患者に注入することを目的とし、あらかじめ設定された流量又は投与量に従って持続的に注入、又はボーラスを制御する装置である。. Health hazards: 当該不具合により、薬液の過量投与の発生が否定できないものの、電子添文および取扱説明書に送液中には定期的に巡回時等に送液状態（薬液の減り具合）を確認する旨の記載があり、医療従事者が本事象の発生を検知することが可能である。また、当該製品及び併用される薬剤の電子添文にも、患者の容態観察を行う旨が記載されて...
Reason: We conducted an investigation following reports from domestic medical institutions that medication was being administered in excess of the set PCA bolus dose when the PCA switch was pressed. The investigation revealed that, due to a software defect, if the user presses and holds the display mode switch to switch to the menu screen while a PCA bolus is being administered, the PCA bolus does not stop, and medication administration continues until the user returns to the flow rate screen. Since this issue could lead to an overdose of medication, we are providing information on usage...
Classification: Class II
Category: medical device recall
Country: Japan
Agency: PMDA-DEVICE
Status: Ongoing

Recall details on Nibble Recalls: https://trynibble.app/recalls/6bd96369-cc36-4755-bcb7-11309255cb8c