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Model Number 673662 |
Device Problems
Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
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Event Description
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The customer reported there was a disconnection of the tube at the mystic junction causing leaking.This was repeatedly seen in multiple bags from the same batch for a home patient.There was no patient harm.
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Manufacturer Narrative
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Investigation summary: the customer reported the tubing disconnected automatically and leaked.There was no patient injury/harm reported.The device history record (dhr) review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.As part of this review, the dimensions of the tubing and mistic connector were reviewed, and all were found to be in specification.A lot and failure mode trend review performed did not identify related trends.One (1) used sample was returned for evaluation.Visual inspection confirmed the report of tubing detachment/disconnection as the silicone tubing was detached from the mistic connector.Functional testing performed required reattaching the tubing to the mistic connector.The set was then connected to a pump and priming was completed without issue.Current process controls require one (1) of every eight (8) manufactured products be inspected with go no go fixture.Quality inspection results for the tensile test at the silicon tubing-mistic connector junction were reviewed and all the samples were found inside specification.A potential root cause of the confirmed detachment at the mistic connector is possible user misuse.The ifu states when loading the feed set to ¿grasp black ring retainer and gently stretch tubing around rotor and insert retainer into right pocket.Corrective actions are not necessary at this time as the historical manufacturing review determined the product met specification.This complaint will be used for tracking and trending purposes.
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Search Alerts/Recalls
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