MAUDE Adverse Event Report: DORNOCH ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Catalog Number ULDU500

Device Problem Leak/Splash (1354)

Patient Problem Eye Injury (1845)

Event Date 06/26/2018

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).K081047; k123188; k133786.Once the investigation has been completed, a follow up mdr will be submitted.

Event Description

It was reported that a staff member inadvertently splashed some enzyme in the eye while adding a new gallon of enzyme.The staff member was not wearing proper protective apparel (eye protection).The event timing was during processing of the cart (during cleaning).This device was not used in the operating room.No additional consequences were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The previous repair record for ultra evacuation unit serial number (b)(4) was reviewed and noted no related non-conformances, requests for deviation (rfd) or any other issues with the repair.The previous repair record review found no issues with the device after repair and all verifications, inspections and tests were successfully completed.Using view 09-23 from the etq reliance system, there were 162 complaints from 26 june 2017 to 30 october 2018 that contained part number: ulev100, complaint description with the keyword: 'enzyme.' the keyword of 'enzyme' was chosen as a filter based upon the reported failure of 'a staff member inadvertently splashed some enzyme in the eye while adding a new gallon of enzyme.' on 27 june 2018, it was reported from memorial hospital of south bend that a staff member inadvertently splashed some enzyme in the eye while adding a new gallon of enzyme.Nsn was contacted about the cart but never dispatched a service technician to be at the site.On 27 june 2018, the nursing manager was contacted via phone, and noted that the affected party 'flushed her eyes for 15 minutes and went to the er to be check out.' she was later discharged, and the account reports that everything was ok at this time.The work order was then closed out as the account had just called in to ask a question the supplier was notified of the event, however at this time the only substantive preventative action recommended is the use of protective eyewear that should be standard practice within the base rule of osha¿s bbp program.The ulez200 product is defined as a moderate eye irritant similar in affect to most surfactant/soap products.Service work order (b)(4) on 27 june 2018.The reported event was never confirmed during inspection of the device however at this time the only substantive preventative action recommended is the use of protective eyewear that should be standard practice within the base rule of osha¿s bbp program.The ulez200 product is defined as a moderate eye irritant similar in affect to most surfactant/soap products.A root cause of the failure cannot be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

Event Description

No additional event information was received.

• Brand Name: ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): DORNOCH; 200 northwest parkway; riverside MO 64150
• MDR Report Key: 7746729
• MDR Text Key: 115915253
• Report Number: 0001954182-2018-00046
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• PMA/PMN Number: K133786
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: ULDU500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other