MAUDE Adverse Event Report: SYXMEX CORPORATION SYSMEX XE-2100 AUTOMATED HEMATOLOGY ANALYZER

Model Number XE-2100

Device Problems Difficult to Remove (1528); Use of Device Problem (1670)

Patient Problem Needle Stick/Puncture (2462)

Event Date 10/08/2015

Event Type  Injury  

Manufacturer Narrative

The event description provides few details.The piercer needle punctured the skin; however, after the operator was handling tubing previously exposed to blood.Universal precautions standards consider all blood, blood products and other bodily fluids to have the potential of carrying blood-borne pathogens and must be regarded as infectious.Possible exposure to any of these substances is considered a serious event.The xe-2100 operator's manual (om) introduction details numerous instructions for safe handling of the analyzer.The user is warned: "always wear protective clothing, gloves, and eyeglasses when performing maintenance or inspection to prevent contact with blood contaminated parts.Use the specified tools and parts.Wash your hands thoroughly following maintenance." no specific tools or parts are included in (om) chapter 3 - maintenance & supplies replacement, section 6.2 replace piercer.The instructions do not recommend using a new injector needle to remove parts.Sysmex corporation performed a review of complaint records and found no instances in which user safety was jeopardized in this manner among (b)(6) analyzers in the past three years.The customer can contact the technical assistance center (tac) in the us when assistance is needed with part or supply replacement.This incident is clearly an accidental exposure.Anyone performing maintenance on equipment is required to follow all directives in the sysmex instructions for use as well as any requirements for ppe.The user suffered an injury that required care.While the event description intimates that particular case was limited to simple first aid measures, as a precaution, post-exposure (b)(6) was believed to have been administered because of the possibility that the operator was exposed to a blood-borne pathogen.

Event Description

The user of an xe-2100 after an incident of possible exposure to blood borne pathogens while the operator was attempting to replace the piercer.A (b)(6) year-old female was performing this "as needed" maintenance procedure.Piercer replacement is required after the existing assembly is used for (b)(6) cycles.A message, "change piercer" is displayed to inform the operator.The operator was attempting to remove the connection tubing.The tubing configuration is such that a teflon tube is contained within a silicon tube.The user is to remove the tubing and a rubber joint that are connected to the rinse cup and piercer in the process.The user was able to remove the silicon tubing from the rinse cup; however, the teflon tubing was not removed and was more difficult to dislodge than anticipated.The user attempted to remove the teflon tubing using a clean injection needle; however, the needle pierced the operator's skin.The needle itself was new, but the teflon tubing previously was contaminated with biohazardous material.The operator was wearing appropriate personal protective equipment (ppe) at the time; however, the needle pierced both gloves and the skin.The operator received a (b)(6) assessment and (b)(6) as a precaution.

• Brand Name: SYSMEX XE-2100 AUTOMATED HEMATOLOGY ANALYZER
• Type of Device: HEMATOLOGY ANALYZER
• Manufacturer (Section D): SYXMEX CORPORATION; 314-2 kitano; noguchichi; kakogawa, hyogo 67-00 11; JA 67-0011
• Manufacturer (Section G): SYSMEX CORPORATION; 314-2 kitano; noguchichi; kakogawa, hyogo 67-00 11; JA 67-0011
• Manufacturer Contact: peter shearstone ; 577 aptakisic road; lincolnshire, IL 60069 ; 2245439514
• MDR Report Key: 5224162
• MDR Text Key: 31180196
• Report Number: 1000515253-2015-00011
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K992875
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Medical Technologist
• Device Model Number: XE-2100
• Device Catalogue Number: 98313411
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2015
• Initial Date FDA Received: 11/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2006
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR