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Catalog Number J2C1711 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/06/2024 |
Event Type
malfunction
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Event Description
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It was reported that a small volume infusor leaked during filling.Furthermore, ¿saline leaked inside the housing¿.This occurred during compounding.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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H4: the lot was manufactured between april 11, 2023 - april 13, 2023.H10: the actual device was received for evaluation.Visual inspection on the returned unit noted fluid contained inside the housing.Further inspection revealed the cause of fluid inside the housing was due to missing upper film-wrap.The upper film-wrap is located at the upper area of the bladder.The upper film-wrap fastens the bladder to the stressmember.When the film-wrap is missing, the bladder does not inflate during fill and the fluid leaks inside the housing.The reported condition was verified.The cause of the missing film-wrap was related to a manufacturing issue.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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