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Catalog Number 2C4711K |
Device Problem
No Flow (2991)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/26/2024 |
Event Type
malfunction
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Manufacturer Narrative
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E1: initial reporter postal code: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported a large volume folfusor did not flow during infusion.A ¿day and a half¿ post infusion initiation, the pump appeared full, and the pump had not infused.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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H4: the lot was manufactured between july 13, 2023 - july 14, 2023.H10: the actual device was received for evaluation containing 119ml fluid in the bladder.A visual inspection was performed, and it was noted that there was no evidence of fluid flowing out at the distal end of the flow restrictor.Microscopic inspection on the flow restrictor revealed the cause of flow problem was due to a series of micro-air bubbles blocking the fluid path inside the lumen of the capillary glass.The reported condition was verified.The cause of the condition was determined to be user related.Air bubbles inside the lumen of the capillary glass can be attributed to improper filling technique during product use (filling step).The product label (ifu, instructions for use) details the proper filling technique to avoid this type of occurrence.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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