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

Model Number 10486890

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/20/2020

Event Type  malfunction  

Manufacturer Narrative

The customer contacted siemens to report that the operator of a dimension exl with loci module (lm) instrument was splashed on the wrist with biohazardous waste while performing maintenance on the instrument.A siemens investigation found that while disconnecting the waste line from the instrument the operator was exposed to the fluid that was inside the container on the right wrist.The individual was wearing personal protective equipment (ppe).But when wearing the lab coat and gloves, the gloves are to be fitted on the outside of the lab coat to prevent skin exposure to the waste liquid.In addition, the operators manual recommends to place a cloth over the waste lines before disconnecting to reduce spills.This was not adhered to along with the gloves not fitting over the lab coat allowing the exposure.A siemens customer service engineer (cse) was dispatched to the customer site after the incident to correct waste bottle full errors generated by the instrument.The cse replaced the waste pump, and ran a system check.The cause of the biohazardous waste exposure was an operator error.The instrument is performing within specifications.No further evaluation of this instrument is needed.

Event Description

The operator of a dimension exl with loci module (lm) instrument was splashed on the wrist with biohazardous waste while performing maintenance on the instrument.The operator did not seek medical attention.There are no known reports of patient intervention or adverse health consequences due to the biohazardous waste exposure.

• Brand Name: DIMENSION EXL WITH LOCI MODULE
• Type of Device: DIMENSION EXL WITH LM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; registration #: 1226181; 101 silvermine road; brookfield DE 06804
• Manufacturer Contact: karl aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9145243102
• MDR Report Key: 10534492
• MDR Text Key: 206965934
• Report Number: 2517506-2020-00280
• Device Sequence Number: 1
• Product Code: JJE
• 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: 09/15/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 10486890
• Device Catalogue Number: 10486890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2020
• Initial Date FDA Received: 09/15/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/26/2009
• 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