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Catalog Number SET001325 |
Device Problem
No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/01/2022 |
Event Type
malfunction
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Event Description
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Customer states the following: "primary occlusion - when backpriming not allowing them to backprime, no patient harm, but delay in treatment.If they change to another pump then this still happens.They had labeled it "primary occlusion".No tubing was clamped.They stated this has been happening just recently and are wondering if it is a tubing issue.No patient harm.No tubing saved, or pictures taken or pump info reported." occurred during an active infusion and a delay in therapy was experienced.2nd of 4 reports as there were 4 instances communicated to fresenius kabi.The first was reported on mdr #3014732157-2022-00028.Reporting due to the referenced technical issue; no adverse effects or serious injuries were reported.More information is needed to complete the investigation.
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Event Description
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Admin set not received from customer, not enough information to replicate issue.No additional information was provided (including lot identification).Due to the limited amount of information received, the event is not confirmed and the root cause remains unknown.Should additional information or samples be made available in the future, the complaint and investigation will be re-opened.
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Search Alerts/Recalls
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