MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD 100NX CASSETTE; STERRAD 100NX STERILIZER

Catalog Number 10144

Device Problem Chemical Spillage (2894)

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

Event Date 03/21/2017

Event Type  malfunction  

Event Description

A customer reported a healthcare worker (hcw) came into contact with h202 while trying to reinsert a 100nx cassette into their sterrad 100nx sterilizer.The customer explained the cassette was not being accepted into the sterilizer and noticed the cell of the cassette was broken and leaking.It is unknown whether or not the hcw was wearing personal protective equipment (ppe) while handling the cassette.There is no reported injury or harm associated with this event.Asp will continue to follow up for additional information.This event is being reported as a malfunction subsequent to a serious injury.

Manufacturer Narrative

Additional information provided by the customer indicates a female health care worker (hcw) made contact with h2o2 on her arm and finger, and the affected area turned white in color with no blisters.This new information suggests the h2o2 skin reaction was not serious; it was white, superficial, with no blisters.The hcw was treated with a topical antibacterial cream and analgesics, and considered first aid.In addition, the skin reaction resolved in five days, and the hcw is working without health problems.There is no report that medical or surgical intervention was required to preclude a permanent impairment of a body function or permanent damage to a body structure.Although there are no serious injuries reported in this complaint, this h2o2 skin reaction was due to the hcw touching a sterrad 100nx cassette; therefore, this event was previously reported as a malfunction subsequent to a serious injury.The batch record review did not reveal any indication on a deviating quality profile for this batch.No anomalies were observed that would contribute to the customer's experienced issue.All in-process controls corresponded to the specification.

Manufacturer Narrative

Asp investigation summary: the investigation included a review of the device batch record, trending analysis by lot number, system risk analysis (sra)and concomitant product evaluation.Supplier product evaluation was not performed since the affected product was not returned for evaluation.Trending analysis by lot number was reviewed from 10/21/2016 to 04/19/2017 and trending was not exceeded.The sra indicates the risk associated with exposure to toxic or corrosive material is "low." the concomitant sterrad 100nx was evaluated by a field service engineer and reported the issue was likely due to the sterrad unit not being clean.The fse cleaned and tested the unit and confirmed the unit was in working condition.The instructions for use (ifu) of the sterrad® 100nx cassette state: "caution: wear personal protective equipment if handling a used cassette, or any of the cassette case components that may have been subject to liquid leak.This includes a cassette that has been ejected (for any reason) after insertion." the issue has been attributed to user error as the healthcare worker (hcw) handled a used cassette without utilizing proper personal protective equipment (ppe).A customer letter was sent advising the customer to wear proper ppe to avoid this issue in the future.Review of tracking and trending data did not reveal a trend.As a result, root cause was not performed; therefore, no further investigation is necessary at this time.

• Brand Name: STERRAD 100NX CASSETTE
• Type of Device: STERRAD 100NX STERILIZER
• 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: 6575100
• MDR Text Key: 75512306
• Report Number: 2084725-2017-00248
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K071345
• 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,Followup
• Report Date: 04/27/2017

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: 09/23/2017
• Device Catalogue Number: 10144
• Device Lot Number: 161098
• Other Device ID Number: 10144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/27/2017
• Initial Date FDA Received: 05/18/2017
• Supplement Dates Manufacturer Received: Not provided; 08/02/2017
• Supplement Dates FDA Received: 06/23/2017; 08/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2016
• 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