MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR; INDICATOR, BIOLOGICAL (FRC)

Catalog Number 14324

Device Problem Chemical Problem (2893)

Patient Problem Bacterial Infection (1735)

Event Date 05/18/2016

Event Type  malfunction  

Manufacturer Narrative

Brand name - the correct brand name is sterrad® chemical indicator strip.Common device - the correct common device is indicator, chemical.Catalog number - the correct catalog number is 14100.

Event Description

A customer reported a sterrad® chemical indicator strips did not change color correctly after a completed sterrad® nx cycle and the affected load was released and used on patients.It was reported that two patients are experiencing bacterial infections and are receiving medical treatment.The two patients are being captured and reported under pi#(b)(4) for patient #1 and (b)(4) for patient #2.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® chemical indicator strips not changing color correctly.Asp will continue to follow up for additional information.This is three of three 3500a reports being submitted for this event.Please reference manufacturer report numbers: 2084725-2016-00346, 2084725-2016-00347 and 2084725-2016-00348.

Manufacturer Narrative

The customer also provided new information and reported there was a ¿bad practice¿ of the hospital¿s decontamination process that was done prior to loading items in the sterrad®.It was also noted the customer was sterilizing items that were not validated in the sterrad® sterility guide.These items include gore-tex prosthesis, dacron prosthesis, an unknown ¿mesh¿, and a ligasure clamp (35.5 cm long).Customer re-training was provided on september 8, 2016.Asp investigation summary: the investigation included a review of the device history record (dhr), system risk analysis (sra), trending of lot number, concomitant product evaluation, product return and retains analysis.The lot number was unavailable, so the dhr review, lot trending history, and retains analysis could not be performed.The sra indicates the risk associated with exposure to biohazardous, pathogenic or infectious material is "low." the product was not returned for functional analysis.Lot number is unavailable; therefore, retains testing could not be performed.The concomitant sterrad® nx was tested by a field service engineer (fse).A successful test cycle was run and confirmed the unit met specifications.There is insufficient information to determine an assignable cause.The lot number was not provided so the dhr, complaint trending and retains testing could not be performed.It is unlikely the sterrad nx unit was related to the complaint issue as the fse confirmed the unit functioned as expected.The customer reported there was a "bad practice" at the hospital's decontamination process that was done prior to loading items in the sterrad.It was also noted the customer was sterilizing items that were not validated in the sterrad sterility guide.Incorrect color change of the chemical indicator could be caused by not following the instructions for use (ifu).Retraining was provided to the customer.The issue will continue to be tracked and trended.

• Brand Name: STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR
• Type of Device: INDICATOR, BIOLOGICAL (FRC)
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer Contact: joaquin kurz ; irvine, CA 92618
• MDR Report Key: 5724967
• MDR Text Key: 47397733
• Report Number: 2084725-2016-00348
• Device Sequence Number: 1
• Product Code: FRC
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K994055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/18/2016

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: 05/31/2016
• Device Catalogue Number: 14324
• Other Device ID Number: 14324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/18/2016
• Initial Date FDA Received: 06/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1