Catalog Number UNKNOWN |
Device Problem
Inaccurate Flow Rate (1249)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/17/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the franklin lakes fda registration number has been used for the manufacture report number.Device expiration date: unknown.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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Event Description
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It was reported that the unspecified bd alaris tubing set experienced flow issues.The following information was provided by the initial reporter: type of incident/problem: malfunction - during or after use.Level of harm: no apparent harm - reached patient/person, inconvenient.Iv with secondary line medication infusing via alaris pump, all clamps open per policy and procedure, fluconazole 400 mg infused? or backed up into primary bag unsure if infused quickly into patient or if all went into the primary bag, pump programmed correctly, independent check provided by writer, primary bag overful.Pump was checked by clinical engineering and ruled out as the issue.Impact of incident: pt asymptomatic, infusion stopped immediately.Pump and line disconnect and new set up to pt provided and labelled accordingly.Who was affected? patient.Frequency of problem: first time.
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Event Description
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It was reported that the unspecified bd alaris tubing set experienced flow issues.The following information was provided by the initial reporter: type of incident/problem: malfunction - during or after use level of harm: no apparent harm - reached patient/person, inconvenient iv with secondary line medication infusing via alaris pump, all clamps open per policy and procedure, fluconazole 400 mg infused??? or backed up into primary bag unsure if infused quickly into patient or if all went into the primary bag, pump programmed correctly, independent check provided by writer, primary bag overful.Pump was checked by clinical engineering and ruled out as the issue.Impact of incident: pt asymptomatic, infusion stopped immediately.Pump and line disconnect and new set up to pt provided and labelled accordingly.Who was affected? patient frequency of problem: first time.
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 23-nov-2022 h6: investigation summary one primary tubing (model 2420-0007) and one secondary tubing were returned by the customer.It was reported by the customer that medication possibly backed up into the primary bag.The samples were examined for defects and abnormalities.No defects or abnormalities were observed.Functional testing was performed by using a primary bag filled with clear saline which was then used to prime the set.The secondary set was connected to a bag filled with a blue dye/water mixture, and then connected to the primary set.The sets were set up in a secondary infusion configuration with the fluid level of the secondary bag at least 9.5 inches higher than the primary bag fluid level, and all of the clamps closed.The secondary set was primed with the secondary roller clamp fully opened.Fluid flow was controlled using the primary roller clamp.Fluid was found to be flowing normally.No back flow was observed.An infusion was completed using the bd alaris pump and pump module at 125 ml/hr with a vtbi of 125 ml.Fluid was flowed into an empty beaker.After 1 hour there was about 125 m/l of saline in the beaker.Fluid was flowing normally.No back flow was observed.The failure was unable to be replicated, and the complaint could not be verified.A root cause was unable to be determined because the failure was unable to be replicated.A device history record review could not be performed on model 2420-0007 because a lot number is unknown.A lot number was attempted to be identified but no lot numbers were found.
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Search Alerts/Recalls
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