Health Canada — Medical Devices · Canada · 2024-05-23 · Type II
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Reported risk: Expanded recall notice to include (Plum A+3 infusion pumps). If a Plum 360 or Plum A+ infusion system is running on battery power, a low battery and depleted battery alarm should typically activate when thirty minutes and three minutes, respectively, of estimated battery runtime remain. In addition, when the pump detects a loss of battery capacity, the pump will display a message to replace the battery. On a Plum 360 pump, the screen will display "keep plugged into ac! service battery / replace pump" and Plum A+ pump will display "warning: replace battery." Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected. If an affected battery is not replaced when the pump displays the message to replace the battery, there may be less than thirty minutes of battery runtime after the low battery alarm resulting in the depleted battery alarm occurring sooner than expected. At this point, the pump stops delivery, alarms depleted battery for three minutes, and the pump turns off. Please note: this recall may also affect spare batteries from CSB, manufactured before January 1, 2023. If the first two characters on the label are 22 or lower, the battery is potentially affected. Recall start date: May 5, 2024
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