Model Number 6400 |
Device Problem
Device Alarm System (1012)
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Patient Problems
Itching Sensation (1943); Skin Inflammation/ Irritation (4545)
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Event Type
Injury
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Manufacturer Narrative
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No further information was provided.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 that the patient had issues with an occlusion alert on the pump and was advised by the prescriber to go to the hospital.No further issues were noticed with the pump.The central catheter line was inserted at the hospital and later it was noted that the line site was red with brown drainage to the site.The patient reported having itchiness to the site and believes it is from the adhesive.Site was noted to have redness, irritation and skin breakdown from the dressing.The patient had a tear in her dressing and stated it was from scratching the site.No further information is known.No further adverse patient effects were reported.
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Manufacturer Narrative
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Date of event is unknown, no information has been provided to date.No product returned to verify or replicate the complaint.No photographic/diagnostic evidence of complaint provided by the customer.The most probable cause of an occlusion is a kink in tubing/disposable.No serial number was provided so a device history record (dhr) review and service history could not be performed.If the product is returned the manufacturer will re-open the complaint for further device analysis.
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Search Alerts/Recalls
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