MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL WITH LM

Model Number DIMENSION EXL WITH LM

Device Problem Leak/Splash (1354)

Patient Problem Corneal Abrasion (1789)

Event Date 03/09/2020

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc) and siemens reviewed the data provided by the customer.Siemens confirmed that the sample probe cleaner is a solution of 2.6% bleach and that the operator did not wear proper eye protection.Wearing personal protective equipment including eye protection should have been used during the trimming of the sample probe cleaner tubing.The instrument is performing according to specifications.No further evaluation of this device is required.

Event Description

Customer was attending to a sample probe cleaner error on a dimension exl with lm instrument, and was splashed in the face from trimming the tubing.The leak did not cause a slip, or trip hazard.Customer was not wearing eye protection.Customer was exposed to potentially hazardous material.The customer sought medical treatment at the facility's emergency room.There are reports of adverse effects to the operator being splashed in the face.

• Brand Name: DIMENSION EXL WITH LM
• Type of Device: DIMENSION EXL WITH LM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark, de
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 101 silvermine road; registration number: 1226181; brookfield, ct
• Manufacturer Contact: eric so ; 511 benedict ave; tarrytown, ny ; 5243067
• MDR Report Key: 9868258
• MDR Text Key: 194952163
• Report Number: 2517506-2020-00111
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00006304145935
• UDI-Public: 006304145935
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIMENSION EXL WITH LM
• Device Catalogue Number: 10486890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/12/2016
• 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