MAUDE Adverse Event Report: SYSMEX CORPORATION, I SQUARE SP-10; SP-10 AUTOMATED HEMATOLOGY SLIDE PREPARATION UNIT

Model Number SP-10

Device Problem Melted (1385)

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

Event Date 12/17/2020

Event Type  malfunction  

Manufacturer Narrative

The analyzer generated pressure errors.The sp-10 troubleshooting ifu, chapter 10 - troubleshooting - causes of errors and remedial actions, displays the various producible errors, and the meanings associated with the errors.The "pressure error" has the following probable causes: during startup, shutdown, or cleaning, another error (pressure error, etc.) prevented the next operation from being performed.The cassette has stopped in the stain pool due to dirt on the cassette.The user is to: resolve the other error, and then follow the instructions in the action message to reset.Clean the cassette, and then follow the instructions in the action message to reset.The sp-10 general information instructions for use (ifu), chapter 2 - safety information, section 2.1 - general information, states, "should the device emit unusual odors or smoke, turn off the power immediately and unplug the power cable.Contact your local sysmex representative.Continuing to use the device may result in fire, electrical shock, or injury".Additionally, "do not damage the power cable.Do not place any heavy objects on the power cable or forcibly pull on the power cable.Risk of fire and electrical shock due to short-circuiting or wire breakage." the user appropriately contacted the sysmex technical assistance center after observing the melted cable.A sysmex service engineer was dispatched and reported the power cord did not appear to be completely plugged into the pu-17.The service engineer replaced the pu-17 and power cord to resolve the issue.The suspect pu-17 and power cord will be examined by sysmex corporation (b)(4) (s-corp) for investigation of root cause.

Event Description

The user of an automatic slide preparer (sp-10) reported the device was generating pressure errors.During troubleshooting, the user opened the sp-10 wagon door where the pneumatic unit (pu-17) is located, and stated the power cord connected to the pu-17 appeared melted.There was no visible smoke, flame or odor.There was no operator harm reported.

Manufacturer Narrative

Sysmex corporation japan (s-corp) determined there was increased electrical resistance between the inlet to the pneumatic unit and the female end of the power cord possibly due to the power cord not being seated completely.This caused the power cord to overheat and melt.No systemic product deficiency was identified.

• Brand Name: SP-10
• Type of Device: SP-10 AUTOMATED HEMATOLOGY SLIDE PREPARATION UNIT
• Manufacturer (Section D): SYSMEX CORPORATION, I SQUARE; 262-11 mizuashi; noguchi-cho; kakogawa-city, hyogo 675-0 019; JA 675-0019
• MDR Report Key: 11091980
• MDR Text Key: 252298575
• Report Number: 1000515253-2020-00033
• Device Sequence Number: 1
• Product Code: KPA
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SP-10
• Device Catalogue Number: BR362571
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1