Alerte De Sécurité sur P series Alaris / Welmed / IVAC infusion pumps: (1) P1000, (2) P2000, (3) P3000. Software Version: (1), (2) and (3): 1,2 and 4

Safety alert

215

2000-12-01

Brazil

ANVISA

http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp

The uk medical devices agency (mda) has issued a risk report demonstrating that a larger infusion than the infusion pumps required may occur, because of a problem in the limit / bolus volume switch, or typographical errors explanation of how to use it. _any pump using the software in version 1 has obsolete software. by pressing the bolus button once, followed by the pressure on the limit button or vice versa, the p1000 series pump with software version 2 can: (1) continue normally; (2) stop, trigger the alarm and restart; (3) continue infusion at the same rate, but not on the monitor; (4) continue infusion at the prescribed dose, however showing the inscription --- on the monitor; (5) activate the alarm ¿er-¿or (6) stop and lock with a continuous alarm. _when using p1000, p2000, or p3000 series pumps with software in version 2, if the bolus dispensed exceeds the limit volume value, the pump will trigger a flashing alarm on the monitor: start / stop, and continue to infuse the dose of the bolus until it reaches the end of the syringe or you press the button to stop the pump. _ there was an error in the guidelines for the use of p1000, p2000 and p3000 series pumps with software version 4. the access codes for "stop at limit volume" are transposed. the mda states that the correct codes are as follows: (1) t-0 kvo continuous infusion in the limit volume alarm and (2) t-1 automatic termination in the limit volume alarm.

MDA recommends the following: (1) Identify any Alaris P1000, P2000 or P3000 Series infusion pump and determine the software version of the pump. (2) Any pump using software in version 1 will be using outdated software, needing to perform an upgrade. For information about this update, contact your local representative or directly to Alaris Medical, by postal service at the above address, or by telephone at 0021-442 (125) 633-0860 (3) Attach a provisional label to the affected pumps to alert users of such anomalies until Alaris Medical provides a permanent label. MDA recommends that this provisional label be worded as follows: (1) For P1000 series pumps using software version 2: ATTENTION ¿MAKE SURE THE INFUSION PUMP IS WORKING NORMALLY AFTER USING THE BOLUS KEY, IF YOU ARE USING THE LIMIT OF VOLUME. (2) For P2000 and P3000 series pumps using software version 2: CAUTION DO NOT EXCEED THE LIMIT VOLUME WHEN YOU ARE GIVING A BOLUS. Consultations with the manufacturer should be addressed to Carlos Sepúlveda, Alaris Medical Systems, by correspondence sent to the mentioned address, or by telephone / fax at 0021-442 (125) 633-0860. Technical or clinical consultations can be addressed to ANVISA's Tecnovigilância