I would like to make everyone aware of ECRI Alert A41112 [Increased occlusion detection alarms]. It covers System Failure Alarms : • Force Sensor BGND Test, • Force Sensor Bridge Test, • Force Sensor Test • OR has repeated occlusion detection alarms in the Alarm History In an Urgent Medical Device Correction letter, Smiths states that a force sensor in the occlusion detector of the above pumps may drift out of calibration, leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. Smiths also states that if the force sensor calibration shift is large enough, the pump will display a System Failure Alarm (including Force Sensor BGND Test, Force Sensor Bridge Test, or Force Sensor Test); however, if the calibration shift is not large enough to trigger a System Failure Alarm, the threshold to detect an occlusion may increase, increasing the time to occlusion detection, or the threshold may decrease, leading to false occlusion alarms. Smiths further states that although shifts in the force sensor calibration may occur over time with any device, an increased potential for such shifts has been reported in devices produced before April 2022 because of mechanical interference between parts of the plunger head assembly. Smiths states that an increase in the threshold to detect an occlusion may result in a delay and interruption of therapy. Smiths also states that a decrease in the threshold to detect an occlusion may result in an interruption of therapy because of false occlusion alarms. Smiths further states that when the pump reports a System Failure Alarm, the pump sounds and displays an audible and visual alarm, and the infusion stops. Smiths states that delay in therapy, or interruption of therapy, could lead to serious harm or death depending on the patient's condition, the therapy involved, and the time for which therapy is interrupted or delayed. Smiths also states that it has received no reports of serious injuries or death related to this problem.
I would like to make everyone aware of ECRI Alert A41112 [Increased occlusion detection alarms]. It covers System Failure Alarms :
• Force Sensor BGND Test,
• Force Sensor Bridge Test,
• Force Sensor Test
• OR has repeated occlusion detection alarms in the Alarm History
In an Urgent Medical Device Correction letter, Smiths states that a force sensor in the occlusion detector of the
above pumps may drift out of calibration, leading to increased occlusion detection times, false occlusion alarms, or a
System Failure Alarm. Smiths also states that if the force sensor calibration shift is large enough, the pump will
display a System Failure Alarm (including Force Sensor BGND Test, Force Sensor Bridge Test, or Force Sensor
Test); however, if the calibration shift is not large enough to trigger a System Failure Alarm, the threshold to detect an
occlusion may increase, increasing the time to occlusion detection, or the threshold may decrease, leading to false
occlusion alarms. Smiths further states that although shifts in the force sensor calibration may occur over time with
any device, an increased potential for such shifts has been reported in devices produced before April 2022 because
of mechanical interference between parts of the plunger head assembly. Smiths states that an increase in the
threshold to detect an occlusion may result in a delay and interruption of therapy. Smiths also states that a decrease
in the threshold to detect an occlusion may result in an interruption of therapy because of false occlusion alarms.
Smiths further states that when the pump reports a System Failure Alarm, the pump sounds and displays an audible
and visual alarm, and the infusion stops. Smiths states that delay in therapy, or interruption of therapy, could lead to
serious harm or death depending on the patient's condition, the therapy involved, and the time for which therapy is
interrupted or delayed. Smiths also states that it has received no reports of serious injuries or death related to this
problem.
What is the biomed code for the Medfusion 4000 model