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Catalog Number 21-7230-24 |
Device Problems
Mechanical Problem (1384); Infusion or Flow Problem (2964)
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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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Manufacturer Narrative
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This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).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.
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Event Description
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It was reported that the pump stopped for reprogramming.When pump restarted, blood was noticed flowing backwards in infusion tubing, cannula removed and re-sited.Infusion recommenced.No patient injury was reported.
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Search Alerts/Recalls
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