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

Catalog Number 10033

Device Problem Device Disinfection Or Sterilization Issue (2909)

Patient Problem Bacterial Infection (1735)

Event Date 05/18/2016

Event Type  Injury  

Manufacturer Narrative

The field service engineer was dispatched to the site on 05/31/16, at that time the customer was informed the unit was working to specification.

Event Description

A customer reported two patients are experiencing bacterial infections from loads not sterilizing properly in the sterrad® nx sterilizer.The cycles complete successfully but the some of the processed chemical indicators are not changing color properly.A cultivation test was performed on the last processed load, and the results of the tests were positive for bacterial contamination.The patients are being treated for the infections, however no further details regarding the cultivation test, patient injuries and medical treatment are known at this time.Asp will continue to follow up for additional information.(b)(4) is being reported for patient #1 and (b)(4) was reported for patient #2.(b)(4) is being reported for the incorrect color change of the chemical indicator strip.This is one 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 stated they did not trace the bacterial contamination back to the sterrad® loads but reported instead that patient #1 was obese and diabetic and had abdominal surgery with a drain placed.The patient was discharged home with wound and drain care which was done by the patient¿s relative.The customer did not know what technique the patient¿s relative used to manage the wound and drain.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).Re-training for this customer was reported to be planned in july 2016.At the time the reporting determination was made, a decision was made to file a fda medwatch report based on limited information, and due to the fact that the customer reported loads where ci strips did not change properly and were released and used on two patients.After further investigation and new information received, these two complaints ((b)(4)) regarding the two patients are deemed not reportable.There is no evidence to trace loads processed in the sterrad® back to either of these two patients.Instead the customer reported traceability of patient contamination back to a surgical patient that was discharged home with a relative doing unknown wound and drain care and to a non-surgical patient in the hospital icu.

• Brand Name: STERRAD NX 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
• MDR Report Key: 5724902
• MDR Text Key: 47392793
• Report Number: 2084725-2016-00346
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K042116
• 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

• Date FDA Received: 06/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 10033
• Device Lot Number: 0033120523
• Other Device ID Number: 10033
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2016
• Date Device Manufactured: 05/01/2012
• 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