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Catalog Number 2C4009K |
Device Problem
No Flow (2991)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/13/2023 |
Event Type
malfunction
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Manufacturer Narrative
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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 large volume folfusor had no flow.This occurred during patient infusion.The balloon remained completely full 48 hours after installation of the device.To resolve the event, the device was prepared again and reconnected.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 october 04, 2022 to october 05, 2022.H10: one actual device was received for evaluation.The unit contained 229ml of fluid in the bladder.A visual inspection on the unit via the naked eye showed no evidence of fluid coming out at the distal end of the flow restrictor.A microscopic examination on 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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