Model Number 1200DY |
Device Problem
Excess Flow or Over-Infusion (1311)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/17/2015 |
Event Type
No Answer Provided
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Event Description
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On (b)(6) 2015, the senior pharmacy technician at clinical specialties had contacted baxter technical services in (b)(4), to report a total of 6 bags that had completed delivery before the scheduled completion.The bags were pumped and infused to 6 patients.All patients are home care patients.The pharmacy had created a batch of total parenteral bags for each patient to bring home for the week.It was reported by the nurses that the infusion pumps used to infuse the bags started alarming.When the nurses checked why the infusion pumps were alarming, the nurses noticed the bags had run dry.In regards to patient status, the senior pharmacy technician indicated that the 6 patients are stable and doing fine.This report is for the (b)(4), female, patient d; 4 of 6 reports from the same event as it involved 6 different patients.
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Manufacturer Narrative
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The evaluation of the data provided from the two em1200 compounders at the customer site showed no evidence the em1200 compounder contributed to the bags prematurely running dry during infusion.Curlin infusion pump instructions provided to patient d: 2 of the bags are to be infused at 3600ml iv two days per week (mon-fri) over 12 hours with a 1 hour taper up and 1 hour taper down via curlin pump.5 of the bags are to be infused at 3600ml iv five days per week (sat, sun, tue, wed, thurs) over 12 hours with a 1 hour taper up and 1 hour taper down via curlin pump.The curlin infusion pumps used to infuse the bags in this event will be reported and reviewed by the manufacturer.Baxter healthcare is not the manufacturer of the curlin infusion pump.Evaluation codes method:data validation order entry labels, compounder mixcheck reports and the black-box data were reviewed and evaluated.Results: user device interface it is unknown how or what caused the nutrition bags to run dry.Conclusion: no failure detected, device operated within specification.The information from the data provided found that the em1200 compounder did not contribute to this event.Device not available for return.
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Search Alerts/Recalls
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