The Medfusion 3500 and 4000 pumps are used to deliver fluids such as blood or antibiotics into patients’ veins. Smiths Medical notified healthcare providers about the problems in April.
The eight software issues, according to the FDA:
1. False alarm system failure
2. Unanticipated depleted battery alarms
3. Abnormal circuit board behavior, which may cause internal clock system failure
4. The infusion could continue after system failure
5. When two differently sized syringes are used during one infusion, the fluid volume tracker will reset to zero
6. The pump could incorrectly display an alarm about the syringe size and its infusion rate
7. Incorrect bolus or loading dose time display
8. Network configuration may affect pump communications
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