Model Number 10013902 |
Device Problem
Complete Blockage (1094)
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Patient Problems
Underdose (2542); Insufficient Information (4580)
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Event Date 12/02/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported that the ext set.2 mf low sorb had flow issues while infusing taxol, leaving "140 cc" left in the bag.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "this was an under infusion incident- once chemo (taxol) infusion was completed there was still 140 cc left over of chemo in the bag.(total volume 608cc)".
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Event Description
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It was reported that the ext set.2 mf low sorb had flow issues while infusing taxol, leaving "140 cc" left in the bag.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "this was an under infusion incident- once chemo (taxol) infusion was completed there was still 140 cc left over of chemo in the bag.(total volume 608cc).".
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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: 1/14/2021.H6: investigation: it was reported that 140 cc of chemo was left over in the bag.A device history record review for model 10013902 lot number 20086307 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The sample(s) were inadvertently misplaced during the chemo decontamination process, but if found, a full investigation will be completed.However, the root cause of this failure was not identified as no product was received to undergo investigation.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of flow issues: accuracy with lot #20086307 regarding item #10013902.
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Search Alerts/Recalls
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