Catalog Number C25012 |
Device Problem
Volume Accuracy Problem (1675)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/15/2023 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device expiration date: unknown.Device manufacture date: unknown.
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Event Description
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It was reported that the bd alaris extension set experienced underinfusion.There was no report of patient impact.The following information was provided by the initial reporter: no alarms, the bags are filled with around 521ml, then about 40ish ml of overfill.We run them at about 23-25ml/hr for 24hrs.A few bags a month ago ran 5 and 7 hours over! no alarms, no air in line alerts.The pump stated it infused 740ml.We filled those bags of saline down in pharmacy to trouble shoot, we couldn¿t even put that much saline in the bags.We had our biomed team troubleshoot the alaris pump and it was found to be calibrated properly.This is the only other step i can think of.Was there any impact or harm due to the reported issue? chemotherapy did not infuse over allotted time of 24 hours.
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Event Description
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It was reported that the bd alaris extension set experienced underinfusion.There was no report of patient impact.The following information was provided by the initial reporter: no alarms, the bags are filled with around 521ml, then about 40ish ml of overfill.We run them at about 23-25ml/hr for 24hrs.A few bags a month ago ran 5 and 7 hours over! no alarms, no air in line alerts.The pump stated it infused 740ml.We filled those bags of saline down in pharmacy to trouble shoot, we couldn¿t even put that much saline in the bags.We had our biomed team troubleshoot the alaris pump and it was found to be calibrated properly.This is the only other step i can think of.¿ was there any impact or harm due to the reported issue? chemotherapy did not infuse over allotted time of 24 hours.
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Manufacturer Narrative
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H6: investigation summary: a photo of the extension set connected to other unidentified sets was provided by the customer.The customer complaint of flow issues - accuracy could not be verified from the photo received.A device history record review could not be performed because the lot number is unknown.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.
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Search Alerts/Recalls
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