MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD 100NX STERILIZER; STERRAD EQUIPMENT (MLR)

Catalog Number 10104

Device Problems Device Disinfection Or Sterilization Issue (2909); Appropriate Term/Code Not Available (3191)

Patient Problems Skin Irritation (2076); No Known Impact Or Consequence To Patient (2692)

Event Date 09/02/2016

Event Type  malfunction  

Manufacturer Narrative

Catalog number - the correct catalog number is 10104-004.(b)(4).

Event Description

A customer reported a healthcare worker (hcw) received a skin reaction to the palm of her left hand and wrist of her right hand, finger and thumb while removing a sterilization bag from the top shelf of their sterrad® 100nx after a completed express cycle.The hcw was not wearing personal protective equipment (ppe), and the affected areas turned white.The hcw rinsed the areas with running water, and the site healed within one day without receiving any medical attention.It was later confirmed the customer had placed items on the top shelf during an express cycle of the sterrad® 100nx and the affected load was released.Although there is no report of any serious 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 loads processed on the top shelf of the sterrad® 100nx sterilizer during an express cycle.

Manufacturer Narrative

Asp investigation summary: the investigation included a review of the device history record (dhr), and system risk analysis (sra).The dhr was reviewed and no issues relating the failure mode were noted.The involved unit met manufacturer specifications at the time of release.The sra shows the risk for exposure to toxic or corrosive material to be "low." the sra shows the risk for biohazardous exposure to be "low." the assignable cause of the issue was due to user error.The customer had placed items on the top shelf during an express cycle of the sterrad 100nx, and the affected load was released and used on patients.Although no injuries were reported, the customer was advised of proper load placement while running loads in the express cycle.The customer was also advised to always wear personal protective equipment (ppe) while handling and removing any loads from the sterrad chamber.The issue was resolved at the customer facility.Asp will continue to track and trend this issue.

• Brand Name: STERRAD 100NX STERILIZER
• Type of Device: STERRAD EQUIPMENT (MLR)
• 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 ; 9497893837
• MDR Report Key: 6058759
• MDR Text Key: 58458854
• Report Number: 2084725-2016-00650
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071385
• 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: 09/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10104
• Device Lot Number: 1044140012
• Other Device ID Number: 10104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1