MAUDE Adverse Event Report: SYSMEX CORPORATION XT-4000I; XT-4000I AUTOMATED HEMATOLOGY ANALYZER

Model Number XT-4000I

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/30/2017

Event Type  malfunction  

Manufacturer Narrative

The analyzer was shipped to the manufacturer for further investigation to determine the root cause of the event.

Event Description

The user reported that the analyzer generated an error message stating "stromatolyser-fb(fba) replace container." this error indicates insufficient reagent, a defective sensor and/or an abnormality in the hydraulic system.A field service engineer (fse) was dispatched and found oxidization on the bubble sensor connector.The wiring attached to the printed circuit board (pcb) was melted and charring was observed.

Manufacturer Narrative

While assessing the analyzer, there was no evidence of leakage from the valve units.However, a short-circuit in wiring cord no.3185 was discovered.The printed circuit board (pcb) and wiring cord charred as a result of excess current.This issue was determined to be an isolated event due to excess current of unknown origin.There was no systemic deficiency identified.No further corrective action will be taken.

Event Description

On may 10, 2017 sysmex corporation (b)(4) (s-corp) received the xt-4000i for investigation.

• Brand Name: XT-4000I
• Type of Device: XT-4000I AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): SYSMEX CORPORATION; 314-2 kitano, noguchi-cho; kakogawa, 675-0 011; JA 675-0011
• Manufacturer (Section G): SYSMEX CORPORATION; 314-2 kitano, noguchi-cho; kakogawa, 675-0 011; JA 675-0011
• Manufacturer Contact: peter shearstone ; 577 aptakisic rd; lincolnshire, IL 60069 ; 2245439514
• MDR Report Key: 6576812
• MDR Text Key: 75516932
• Report Number: 1000515253-2017-00018
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K091313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 05/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Model Number: XT-4000I
• Device Catalogue Number: BY539823
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2009
• 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