Catalog Number 8065752437 |
Device Problem
Obstruction of Flow (2423)
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Patient Problem
Insufficient Information (4580)
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Event Date 10/19/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation, including root cause analysis, is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).
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Event Description
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A customer reported silicon oil clogged tubing.The product was replaced and the procedure was completed.There was no patient harm.
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Manufacturer Narrative
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A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.The returned samples were visually inspected and no obvious defects were found.The non-invasive flow sensor (nifs) on the cassette housing was in good condition.A calibrated console representing the current software version was used to test the sample.The ball in the drip chamber¿s check valve moved freely per specification.The led (light-emitting diode) rings on the console turned green as the probe connectors were engaged to the console indicating the proper communication between the probe and the console.The samples could prime and pass iop (intraocular pressure) calibration successfully.No anomalies were observed during priming.No system message code was generated during testing.Fluid flowed from the bss (balanced salt solution) bottle to the drain bag without any interfering.No leakage was detected from the pump elastomer or on the pump area of the fluidics module.Cleaning process was able to be performed after functional test had completed.The vfc (viscous fluid control) tubing set was inserted into the lab stock syringe for testing.The rubber residue on the black o-ring of the adopter transferred to the inner wall at the entrance of the syringe barrel.The vfc adapter seal ring was not sheen comparing with the one in the lab stock.The dull surface and the hardness on the rubber adapter seal ring interfered the syringe to engage into the adapter.The investigation determined the failure mode was related to dull surface and the hardness on the rubber adapter seal ring.Analysis of the sample could not conclusively determine the root cause of the failure mode with the current information available.Two potential contributors could be related to either a supplier manufacturing error of the rubber seal ring or an assembly error during manufacturing.Action will not be taken for this occurrence as the root cause is not known.After an investigation of this complaint and analysis of complaints of this nature confirm no unfavorable trend for this event.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.Consumables manufacturing management has been made aware of this complaint through the consumer affairs review meeting.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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