Catalog Number 20390 |
Device Problem
Use of Device Problem (1670)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/14/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The customer was retrained on the correct rinsing procedure to include a total of three rinses as per the cidex opa solution ifu, and the customer provided that they have since switched to processing with medivator machines.The batch history record was reviewed and no issues relating to the failure mode were noted.The involved unit met manufacturer specifications at the time of release.Asp complaint ref #: (b)(4).
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Event Description
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A customer reported that their facility did not follow the cidex® opa solution instructions for use (ifu) for instrument rinsing, and the instruments were released and used on patients.The facility confirmed there were no patient symptoms and no injuries reported.Per the cidex® opa solution instructions for use (ifu), a minimum of three one-minute rinses are required using large volumes of fresh water.It was reported that there was human contact with a medical device that was not rinsed per cidex® opa solution ifu; therefore, this event is being reported as a malfunction subsequent to a previous serious injury.
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Manufacturer Narrative
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Asp investigation summary: the investigation included a review of the device batch record, retains testing of lot, trending analysis by lot number, and system risk analysis (sra).Retains testing was completed with no issues identified.All in-process controls are within specifications.Trending analysis by lot number was reviewed for the six months prior to open date and trending was not exceeded.Review of risk documentation shows the risk for residual exposure to be "low." the product was not available for further evaluation.The issue has been attributed to user error as the healthcare worker (hcw) was not following the rinsing procedure in the cidex opa solution instructions for use.The issue will continue to be tracked and trended.Asp complaint ref #: (b)(4).
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Search Alerts/Recalls
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