Model Number 30883 |
Device Problems
Stretched (1601); Obstruction of Flow (2423)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/13/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Medical 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 pca asv microbore tubing had ballooned near where it entered into the channel, and the pump was stopped with the remaining "28.6ml" of "doxorubicin".This complaint was created to capture the 4th of 6 related incidents.The following information was provided by the initial reporter: "date reported: 2/25; extent of harm: reached the individual: ballooning of iv tubing product.Item: alaris pump iv module & bd alaris 3-port tubing: item and lot number: being investigated currently.Item currently being reviewed by clinical engineering alongside with the alaris channel.Doxorubicin medication pump continued to state that "patient side was occluded",no visible occlusion or bent tubing, once i opened the channel on pump, visible ballon on tubing that goes inside channel.Pump was stopped with 28.6ml remaining of medication.".
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Event Description
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It was reported that the pca asv microbore tubing had ballooned near where it entered into the channel, and the pump was stopped with the remaining "28.6ml" of "doxorubicin".This complaint was created to capture the 4th of 6 related incidents.The following information was provided by the initial reporter: "date reported: 2/25; extent of harm: reached the individual: ballooning of iv tubing product.Item: alaris pump iv module & bd alaris 3-port tubing: item and lot number: being investigated currently.Item currently being reviewed by clinical engineering alongside with the alaris channel.O doxorubicin medication pump continued to state that "patient side was occluded",no visible occlusion or bent tubing, once i opened the channel on pump, visible ballon on tubing that goes inside channel.Pump was stopped with 28.6ml remaining of medication.".
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Manufacturer Narrative
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The following fields were updated due to corrected information: device available for eval?: no.Returned to manufacturer on: na.Investigation: a complaint of tubing ballooning was received from the customer.A photo was provided to aid in the investigation of this defect.In the photo it was observed that the tubing below the upper filament was ballooning during infusion.The customer complaint was verified.A device history record review could not be performed on model 30883 because a lot number was not provided by the customer.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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