MAUDE Adverse Event Report: BECKMAN COULTER IRELAND INC. ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM; METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)

Model Number 2.5 ICHEM VELOCITY INSTRUMENT COMPUTERLESS BRING UP TESTED I

Device Problem Leak/Splash (1354)

Patient Problems Exposure to Body Fluids (1745); No Patient Involvement (2645)

Event Date 03/31/2019

Event Type  Injury  

Manufacturer Narrative

The field service engineer (fse) arrived to the customer¿s site and detected that the waste drain tubing was dislodged from the drain port.The fse replaced the tubing to resolve the leak of the customer's ichemvelocity automated urine chemistry system.The waste drain tubing may contain chemical fluids such as iwash and lamina.The safety data sheets (sds) for these items indicate that these chemical fluids are not considered to be hazardous.There is also the likelihood that urine was present at the time of the leak.The liquid was reported to have come into direct contact with the customer¿s eyes, nose, mouth, clothing and hands, confirming there was exposure to the mucous membrane with biohazardous material.(b)(4).

Event Description

The customer reported that the drain hose (drain tubing) dislodged (popped-off) from the right side of their ichemvelocity automated urine chemistry system and sprayed approximately 20 milliliters (ml) of a pressurized fluid which the customer states was a clear reagent and waste material.The customer noticed that the drain tubing continued to pop-off of their instrument.When the drain tubing became disconnected, the customer stated that there was fluid that sprayed from the drain tubing.The liquid from the drain tubing was reported to have sprayed onto the customer causing the liquid to come into direct contact with the eyes, nose, mouth, clothing and hands.The customer technical support specialist (cts) there was direct exposure to open wounds and/or mucous membranes that resulted with the customer seeking medical attention.The customer did have personal protective equipment (ppe) which consisted of gloves, laboratory coat and eye protection at the time of the event.There were no erroneous results that were generated or reported outside of the customer¿s laboratory as a result of this event.

Manufacturer Narrative

Follow up 02: manufacturing site name and address updated to show correct information.Bec internal identifier - case(b)(4).

Manufacturer Narrative

Clarification to initial report: the initial report stated that there was one operator that had come into contact with a biohazardous liquid.Upon further review it was found to be two operators that were sprayed with the liquid.Per follow up with the customer on 04 december 2018, there was only one operator that was confirmed to have direct exposure.There were several attempts made by customer technical specialist (cts) on november 8, 2018, november 9th 2018 and november 15th 2018 to obtain additional information regarding the second end user (the customer's co-worker) and no additional information was provided.The information available is not enough to determine the severity of exposure to the second operator.It was confirmed that the liquid from the drain tubing sprayed onto the first operator causing the liquid to come into direct contact with the eyes, nose, mouth, clothing and hands.Bec internal identifier - (b)(4).

• Brand Name: ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM
• Type of Device: METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)
• Manufacturer (Section D): BECKMAN COULTER IRELAND INC.; lismeehan; o¿callaghan¿s mills; co. clare ; EI
• MDR Report Key: 8122592
• MDR Text Key: 129024472
• Report Number: 1061932-2018-01049
• Device Sequence Number: 1
• Product Code: JIL
• UDI-Device Identifier: 10837461001751
• UDI-Public: (01)10837461001751(11)NO-DATA
• Combination Product (y/n): N
• PMA/PMN Number: K171083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2.5 ICHEM VELOCITY INSTRUMENT COMPUTERLESS BRING UP TESTED I
• Device Catalogue Number: 700-7177-001
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/31/2018
• Date Manufacturer Received: 04/09/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other