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Catalog Number 21-7230-24 |
Device Problem
Reflux within Device (1522)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/23/2020 |
Event Type
malfunction
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Event Description
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It was reported that pump stopped for reprogramming and when pump restarted, blood was noticed flowing backwards in infusion tubing.Cannula removed and re-sited.Pump worked without problem, infusion delivered.No patient injury was reported.
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Manufacturer Narrative
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A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.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.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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Manufacturer Narrative
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Other, other text: corrected data: b1, corrected data: corrected data: b1-product problem.
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Search Alerts/Recalls
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