Model Number 2426-0007 |
Device Problem
Complete Blockage (1094)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/23/2021 |
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 patient¿s age was used to determine a placeholder date for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: one video was taken by the customer which verifies that solution from the secondary bag is flowing into the primary bag.No further investigation can be done as the sample was not returned.The root cause could not be determined because the sample was not returned for investigation.A device history record review could not be performed because a model and lot number was not provided by the customer.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Per bd corrective and preventive action (capa) corporate procedure, the reported issue does not represent a single significant incident that would trigger a capa.
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Event Description
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It was reported two unspecified bd¿ infusion sets had flow issues.The following information was provided by the initial reporter: "nurse recognized that antibiotic infused quicker than it should have.Hung a bag of potassium immediately after that and closely watched the drip chamber.She noticed that the potassium infusion looked to be infusing significantly quicker than it should have been.".
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Event Description
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It was reported two alaris pump module smartsite infusion sets had flow issues.The following information was provided by the initial reporter: "nurse recognized that antibiotic infused quicker than it should have.Hung a bag of potassium immediately after that and closely watched the drip chamber.She noticed that the potassium infusion looked to be infusing significantly quicker than it should have been.".
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Manufacturer Narrative
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The following information has been updated: b.5.Describe event or problem: it was reported two alaris pump module smartsite infusion sets had flow issues.The following information was provided by the initial reporter: "nurse recognized that antibiotic infused quicker than it should have.Hung a bag of potassium immediately after that and closely watched the drip chamber.She noticed that the potassium infusion looked to be infusing significantly quicker than it should have been." d.1.Medical device brand name: bd alaris pump module smartsite infusion set d.2.Medical device manufacturer: sistemas medicos alaris, s.A.De c.V.D.4.Medical device catalog #: 2426-0007.D.4.Unique identifier (udi) #: (b)(4).D.10.Device returned to manufacturer?: yes.D.10.Date received by manufacturer: 11-nov-2021.G.1.Manufacturing location: sistemas medicos alaris, s.A.De c.V.G.5.Pma/510(k)#: k944320.H.6.Investigation summary: one video was taken by the customer which verifies that solution from the secondary bag is flowing into the primary bag.One sample was returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The primary set was primed with normal saline.A bd secondary set was primed with blue dye water and attached to the primary set.No back flow was observed.The customer complaint that the infusion is happening quicker than it should have could not be replicated.The root cause could not be determined because the issue could not be replicated.A device history record review could not be performed on model 2426-0007 because a lot number is unknown.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
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Search Alerts/Recalls
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