Model Number 2426-0007 |
Device Problems
Inaccurate Flow Rate (1249); Air/Gas in Device (4062)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/17/2022 |
Event Type
malfunction
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Event Description
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It was reported that air in the bd alaris¿ pump module smartsite¿ infusion set line caused flow issues, infusing the potassium phosphate bag in 15 minutes rather than 1 hour.The following information was provided by the initial reporter: "beside rn started electrolyte replacement potassium phosphate bag, programmed alaris pump using drug library and set the medication to infuse over 1hr.After 15 min bedside nurse responds to pump alarm, notices pump was alarming due to air in tubing, medication bag was empty.Bedside rn notified physician, patient didn't display any physical distress.Md asked to notify pharmacist.Pharmacist notified.The author discovered the event during rounds".
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Manufacturer Narrative
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Medical device expiration date: unknown.Fda notified?: the initial reporter also notified the fda via medwatch # mw5114413.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Manufacturer Narrative
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H6: investigation summary: no product or photo was returned by the customer.It was reported by the customer that the tubing had improper flow and air in the line.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model 2420-0007 because a 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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Event Description
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It was reported that air in the bd alaris¿ pump module smartsite¿ infusion set line caused flow issues, infusing the potassium phosphate bag in 15 minutes rather than 1 hour.The following information was provided by the initial reporter: "beside rn started electrolyte replacement potassium phosphate bag, programmed alaris pump using drug library and set the medication to infuse over 1hr.After 15 min bedside nurse responds to pump alarm, notices pump was alarming due to air in tubing, medication bag was empty.Bedside rn notified physician, patient didn't display any physical distress.Md asked to notify pharmacist.Pharmacist notified.The author discovered the event during rounds.".
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Search Alerts/Recalls
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