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Device Problems
Device Alarm System (1012); Increase in Pressure (1491); Pressure Problem (3012)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Event Description
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It was reported the pump alarmed high pressure.Patient did a new cassette mix, and new tubing and made sure there are no kinks/ blockage.Patient was advised to go to er to get treatment.Patient's pump stop working and infusing medication.Patient tried to complete new mix with new tubing and cassette and still was getting error.The patient was advised to visit to the er, no patient injury.
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Manufacturer Narrative
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Other text: no product was returned.We are unable to confirm the reported complaint.If the product is returned, the manufacturer will reopen this complaint for further investigation.The most probable cause for a high-pressure alarm, if there are no kinks in the tubing as customer has stated, is a faulty dso sensor; however, this cannot be confirmed as no product was returned for investigation.The service history review identified no indication that the complaint was related to a service of the device within the review period.G2 email is: regulatory.Responses@icumed.Com.
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Search Alerts/Recalls
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