MAUDE Adverse Event Report: BECKMAN COULTER IRELAND NAVIOS FLOW CYTOMETER SYSTEM; FLOW CYTOMETRIC REAGENTS AND ACCESSORIES.

Model Number	TN,NAVIOS 10 COLORS/3 LASERS
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The navios flow cytometer system generated a ¿waste overflow¿ error indicating a system issue.The customer failed to follow the published instructions.The operator attempted to clean the waste (drip) chamber.Per navios ifu, pn a96247ae: overflow error - the drip or waster container has overflowed and the acquisition has been stopped- contact your local beckman coulter (bec) representative.Beckman coulter, inc.Urges its customers and employees to comply with all national health and safety standards such as the use of barrier protection.This may include, but is not limited to, protective eyewear, gloves, and suitable laboratory attire when operating or maintaining this or any other automated laboratory analyzer.The fluid exposure to the operator's eye was as a result of use error.The operator was only wearing gloves to perform the troubleshooting that is recommended to be done by bec representative.Fluid from the syringe (contents of waste chamber) was checked on a hematology instrument and no cells were found.Per the facility exposure control/ risk management plan, serological were performed.In an abundance of caution bec is reporting the event.
Event or Problem Description
The customer reported that their navios flow cytometer system was generating sheath/waste overflow errors.In an attempt to troubleshoot, the operator tried to empty the waste chamber with a syringe and a tubing popped off splashing a small amount of fluid into the eye of the operator.The operator was wearing only gloves as their personal protective equipment (ppe) at the time of the incident.Erroneous patient results were not generated and there was no change or effect to patient treatment in connection to the event.Medical intervention was no required, only serological testing was performed as required by the facility exposure plan.

• Brand Name: NAVIOS FLOW CYTOMETER SYSTEM
• Common Device Name: FLOW CYTOMETRIC REAGENTS AND ACCESSORIES.
• Manufacturer (Section D): BECKMAN COULTER IRELAND; lismeehan; o' callahgan's mills; county clare ; EI
• MDR Report Key: 9090247
• Report Number: 1061932-2019-01820
• Device Sequence Number: 2425260
• Product Code: OYE
• UDI-Device Identifier: 15099590515522
• UDI-Public: (01)15099590515522(11)170310
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K130373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TN,NAVIOS 10 COLORS/3 LASERS
• Device Catalogue Number: A52103
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 09/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other