MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD® VELOCITY¿ BI; INDICATOR, BIOLOGICAL (FRC)

Catalog Number 43210

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

A customer reported a positive result with a sterrad® velocity¿ biological indicator (bi) after a completed sterrad® cycle.The bi was incubated for 30 minutes.The chemical indicator (ci) changed color correctly.The previous and subsequent bi results were both negative.The affected load was released and used on a patient.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 positive sterrad® velocity¿ biological indicators when the loads have been released for use prior to reprocessing.

Manufacturer Narrative

The investigation included a review of the device history record (dhr), trending of lot number, system risk analysis (sra), visual analysis and retains analysis.The dhr was reviewed and the involved lot met manufacturer specifications at the time of release.No anomalies were observed that would contribute to the customer's experienced issue.Trending analysis by lot number was reviewed from 05/05/2018 to 08/28/2018 and trending was not exceeded.The sra indicates the risk associated with exposure to biohazardous, pathogenic or infectious material is "low." the customer stated the bi was discarded and not available for return and visual analysis.Twenty-two retains bis were subject to functional evaluation.All twenty-two bis met specification.The assignable cause could not be verified.It is unlikely the suspected positive bi was caused by a manufacturing issue as the retains met functional specification, dhr review found no anomalies that would contribute to a positive bi result and lot history review found trending was not exceeded in this lot.An issue with sterrad performance is also unlikely as the cycle passed and the chemical indicator disc changed correctly.The customer stated the previous and subsequent bi was negative for growth.The customer reported that they had been having problems with the wells in the velocity incubator.It is most likely a software issue and most likely the cause of the reported bi issue.The velocity reader was returned and the customer received a replacement.The issue will continue to be tracked and trended.Asp complaint ref #: (b)(4).

• Brand Name: STERRAD® VELOCITY¿ BI
• Type of Device: INDICATOR, BIOLOGICAL (FRC)
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 7869172
• MDR Text Key: 120099823
• Report Number: 2084725-2018-00703
• Device Sequence Number: 1
• Product Code: FRC
• UDI-Device Identifier: 10705037048908
• UDI-Public: 10705037048908
• Combination Product (y/n): N
• PMA/PMN Number: K994055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2019
• Device Catalogue Number: 43210
• Device Lot Number: 1251827
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/28/2018
• Initial Date FDA Received: 09/12/2018
• Supplement Dates Manufacturer Received: 10/17/2018
• Supplement Dates FDA Received: 10/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STERRAD® VELOCITY¿ READER SERIAL # (B)(4)