Model Number 10013902 |
Device Problems
Break (1069); Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/28/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that the ext set.2 mf low sorb experienced device damage while still considered operable.The following information was provided by the initial reporter: filter cracked.
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Manufacturer Narrative
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H.6.Investigation: two samples were received for quality investigation.The customer complaint of component damage - leak was verified by investigation.The samples were first visually evaluated for any cracks or damages to the components of the assembly.There were no clearly apparent cracks or damages to the assembly.The samples were then tested for leaks by attaching a syringe to the extension set and pushing water through each set.Leakage was instantly noted through the vents on each of the infusion sets.A device history record review could not be performed on model 10013902 because a lot number was not provided by the customer.The root cause for the issue seen in this complaint is that the filter vents were wetted out during usage causing the filters to leak.The filters were sent to the manufacturer for investigation and the investigation did not reveal any issues with the filter itself, however, both filters showed discolored membrane and it is most likely that the fluids used by the customer caused the vent membranes to become saturated creating the leakage.
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Event Description
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It was reported that the ext set.2 mf low sorb experienced device damage while still considered operable.The following information was provided by the initial reporter: filter cracked.
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Search Alerts/Recalls
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