MAUDE Adverse Event Report: PVT PROBENVERTEILTECHNIK GMBH SYSMEX TS-500XN TUBE SORTER

Model Number TS-500XN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Hematoma (1884)

Event Date 05/19/2015

Event Type  Other  

Event Description

The user of an xn-9000 analysis system, serial number (b)(4), operated with a ts-500xn tube sorter, serial number (b)(4), reported an incident in which a lab tech was injured as she was walking past a tray as it was ejecting from the equipment.The user stated that the tray popped out abruptly because it was full.As it ejected, it hit her on the thigh above the knee cap, causing a hematoma and abrasion.Photographs were submitted to illustrate.The skin was not punctured and bleeding is not evident on the photo provided.The tech sought medical attention.The abrasion was cleaned and she was administered a tetanus shot.She was sent home with instructions to ice the area.No report of malfunction was received.A technical product manager was consulted.He stated that an alarm sounds when the tray is full.The tray is ejected approximately three to four inches out of its locked position, but an alarm sounds to alert the operator prior to occurring.The error log was not retrieved and the user supplied no documentation of malfunction.The photo of the equipment location submitted by the user demonstrates that the tray extends approximately 12 to 16 inches from the counters upon which the tube sorter is located.This indicates operator intervention.The photo also demonstrates congestion in the vicinity of the ts-500xn.The ability to move freely in the area appears restricted because of location of an adjacent bench and operator chairs in the area.

• Brand Name: SYSMEX TS-500XN TUBE SORTER
• Type of Device: TUBE SORTER
• Manufacturer (Section D): PVT PROBENVERTEILTECHNIK GMBH; waiblingen ; GM
• MDR Report Key: 4869373
• MDR Text Key: 20756722
• Report Number: MW5043227
• Device Sequence Number: 1
• Product Code: JQP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/19/2015

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?: No
• Device Operator: Health Professional
• Device Model Number: TS-500XN
• Device Catalogue Number: AN763061
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/22/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other