Catalog Number 2426-0500 |
Device Problem
Air/Gas in Device (4062)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/18/2021 |
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 (b)(4) fda registration number has been used for the manufacture report number.Date of birth: unknown.The patients age was used to determine a placeholder date for this field.Medical device expiration date: unknown.The initial reporter also notified the fda via medwatch # (b)(4).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" infusion set tubing in the iv channel had air in it during use.The following information was provided by the initial reporter: "iv pump was alarming, nurse went to troubleshoot pump.Removed tubing from channel chamber and saw tubing had malfunctioned.The portion of tubing enclosed in iv channel has large inflated area causing it to alarm which then was discovered by nurse when troubleshooting alarming iv pump.".
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Manufacturer Narrative
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The following fields were updated due to additional information: b5: describe event or problem: it was reported that the as lvp 20d dehp 3ss cv tubing in the iv channel had air in it during use.The following information was provided by the initial reporter: "iv pump was alarming, nurse went to troubleshoot pump.Removed tubing from channel chamber and saw tubing had malfunctioned.The portion of tubing enclosed in iv channel has large inflated area causing it to alarm which then was discovered by nurse when troubleshooting alarming iv pump.".D2: medical device brand name: as lvp 20d dehp 3ss cv.D4: medical device catalog #: 2426-0500.D4: udi # (b)(4).G.5.Pma / 510(k)#: k944320.D10: device available for eval yes.D10: returned to manufacturer on: 2021-09-20.Investigation summary: one sample (model #2426-0500) was returned by the customer.It was reported that the portion of tubing enclosed in iv channel has large inflated area causing it to alarm which then was discovered by nurse when troubleshooting alarming iv pump.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was successfully primed.The set was infused with the bd alaris pump module (dchu-0008) at 125 ml/hr with a vtbi of 125 ml.No bulging was observed in the tubing throughout the infusion and after the infusion.The failure was unable to be replicated, and the complaint could not be verified.A device history record review could not be performed on model 2426-0500 because a lot number was not provided by the customer.A root cause was unable to be determined because the failure was unable to be replicated.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
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Event Description
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It was reported that the as lvp 20d dehp 3ss cv tubing in the iv channel had air in it during use.The following information was provided by the initial reporter: "iv pump was alarming, nurse went to troubleshoot pump.Removed tubing from channel chamber and saw tubing had malfunctioned.The portion of tubing enclosed in iv channel has large inflated area causing it to alarm which then was discovered by nurse when troubleshooting alarming iv pump.".
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Search Alerts/Recalls
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