Catalog Number D2C4700K |
Device Problem
No Flow (2991)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/12/2023 |
Event Type
malfunction
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Manufacturer Narrative
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E1: initial reporter facility name: (b)(6).E1: initial reporter address: (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 that a small volume folfusor had no flow.The pump was still full, with 94 ml of sodium chloride after seven (7) days of therapy.The issue occurred during use.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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H10: the device was received for evaluation.The unit contained 89 mls of fluid in the bladder.A visual inspection with the naked eye was performed which showed no evidenced of fluid flowing out at the distal end of the flow restrictor.A microscopic examination of the flow restrictor revealed the cause of the flow problem was due to a series of micro-air bubbles blocking the fluid path inside the lumen of the capillary glass.The capillary glass is located inside the flow restrictor housing.The reported condition was verified.The cause of the condition was determined to be user related as air bubbles inside the lumen of the capillary glass can be attributed to improper filling technique during product use (filling step).The product¿s 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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