ADVANCED STERILIZATION PRODUCTS STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR; INDICATOR, BIOLOGICAL (FRC)
|
Back to Search Results |
|
Catalog Number 14324 |
Device Problems
Chemical Problem (2893); Device Operates Differently Than Expected (2913)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 05/12/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
The correct brand name is sterrad® sealsure chemical indicator tape.The correct common device is indicator, chemical.The correct catalog number is 14202_90, lot # 19716.
|
|
Event Description
|
A customer reported the sterrad® sealsure chemical indicator tape did not change color correctly after a completed sterrad® nx cycle.The affected load was reprocessed.There was no report of infection, injury or harm to patient(s) associated with this issue.Although there is no report of patient injury or harm and no prior incidents have resulted in serious injury, advanced sterilization products (asp) has determined in this situation sterility cannot be assured.Therefore, as a matter of policy asp had decided to report all incidents of sterrad® sealsure chemical indicator tape not changing color correctly.
|
|
Manufacturer Narrative
|
Asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis by lot number, system risk analysis (sra), visual analysis, retains analysis and concomitant product evaluation.The dhr was reviewed and all process specifications were met before release of the product.Trending analysis by lot number was reviewed from 11/13/2016 to 5/12/2017 and trending was not exceeded.The sra indicates the risk associated with a quality problem with no impact on safety is "low." the product was not returned; therefore, no visual analysis was performed.Retains testing was not performed since the ci strips changed color properly when a load was processed in another unit.The concomitant sterrad nx was tested by a field service engineer.Parts were replaced for a procedural related issue and the unit was brought back to specifications.It is inconclusive whether the maintenance performed was related to the complaint issue.There is insufficient information to determine an assignable cause.The product was not returned for evaluation and analysis.Should additional information become available, the complaint file will be re-opened and re-evaluated.The issue will continue to be tracked and trended.
|
|
Search Alerts/Recalls
|
|
|