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

Model Number DIMENSION EXL WITH LOCI MODULE

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/09/2020

Event Type  malfunction  

Manufacturer Narrative

The customer contacted siemens to report a burning smell and that smoke was observed emanating from a dimension exl with loci module (lm).The customer reportedly followed internal procedures for diverting any specimens in need of testing.A siemens customer support engineer (cse) was dispatched to the customer site to inspect the instrument.The cse found that a reagent leak had occurred in the reagent 1 (r1) metering pump area of the instrument.The cse replaced the metering pump, sensor and sample probe cleaner tubing.The cse primed the r1 metering pump and sample probe cleaner.The cse ran daily maintenance and quality control materials level 1 and level 3 with acceptable results.The cause of the burning smell and smoke was a reagent leak in the r1 metering pump area.The instrument is performing within specifications.No further evaluation of the instrument is needed.

Event Description

The customer reported a burning smell and that smoke was observed emanating from a dimension exl with loci module (lm).The instrument generated error codes 137 and 138 reagent 1 metering pump lost steps.The instrument was taken off-line.There are no reports of patient intervention or adverse health consequences due to the burning smell and observed smoke.

• Brand Name: DIMENSION EXL WITH LOCI MODULE
• Type of Device: DIMENSION EXL WITH LOCI MODULE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark, de
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; registration #: 1226181; 101 silvermine road; brookfield, de
• Manufacturer Contact: karl aebig ; 511 benedict ave; tarrytown, ny ; 5243102
• MDR Report Key: 9905480
• MDR Text Key: 195155924
• Report Number: 2517506-2020-00124
• 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: 03/31/2020

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: DIMENSION EXL WITH LOCI MODULE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2020
• Initial Date FDA Received: 03/31/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/08/2010
• 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