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Device Problems
Device Alarm System (1012); Audible Prompt/Feedback Problem (4020)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported device had a faulty microbore extension set tubing.Stated when priming, the tubing starts to fill up about 3 inches and the pump alarms for pressure.No blockage detected on visual examination per reporter.Issue still presents even when changing out the tubing.Secondary device utilized with alternate tubing sets and reported as functioning.Patient was able to successfully continue infusion.The issue was resolved.Battery changes per ifu were also discussed.Advised batteries should be changed every 3-4 days, as opposed to every 7 days which was relayed as current schedule.No patient injury reported.
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Manufacturer Narrative
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Catalog number is unknown.Udi information is unknown.No information provided to date.Lot number is unknown.Premarket (510k) number is unknown.Lot number was provided.However, deemed invalid.Therefore, device history record review could not be completed.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.
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Manufacturer Narrative
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Other, other text: this mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.Update: d1, h6, h10, corrected data: d4: brand name, g7, previously submitted 03-apr-2023.
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Search Alerts/Recalls
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