MAUDE Adverse Event Report: SYSMEX RA CO. LTD. SYSMEX CF-70; CONNECTION UNIT FOR DI-60

Model Number CF-70

Device Problem Problem with Software Installation (3013)

Patient Problem No Patient Involvement (2645)

Event Date 02/28/2020

Event Type  malfunction  

Manufacturer Narrative

It was determined that a software mismatch between the cf-70 and sp-50 caused this event.When the software versions are not matched, and an error condition occurs requiring the operator to open the door of the cf-70 to remove slides or slide magazines from the cf-70, the operation of the cf-70 does not halt.When the software versions are matched, all operation of the cf-70 correctly halts when the door is opened.The software mismatch was due to a servicing error by the service engineer (se) in not verifying that the software version on the cf-70 and sp-50 matched after installing the software.The se reinstalled the software and verified that the software versions matched between the cf-70 and the sp-50 to resolve the issue.After the software versions matched, operation halted while the cover door of the cf-70 was open.Conclusion code suggestion: servicing error.

Event Description

During installation of a cf-70 (connection unit for di-60), a sysmex employee reported that the operation of the cf-70 did not stop upon opening of the cover door.The cf-70 delivers stained blood smears prepared on the sp-50 (automated hematology slide preparation unit) to the di-60 (automated digital cell morphology analyzer) and stores smears for which analysis has been completed on the di-60.When running samples through the cf-70, multiple errors were generated and displayed on the sp-50.An alarm was also heard.Following directions on the sp-50 screen, the sysmex employee opened the cf-70 door to resolve the errors.When the sysmex employee inserted their hand to remove slides and magazines, a noise associated with mechanical movement was heard and the cf-70 arm was observed to be moving.The sysmex employee removed their hand and no harm was incurred.

• Brand Name: SYSMEX CF-70
• Type of Device: CONNECTION UNIT FOR DI-60
• Manufacturer (Section D): SYSMEX RA CO. LTD.; 1850-3 hirookanomura; shiojiri, nagano 399-0 702; JA 399-0702
• Manufacturer (Section G): SYSMEX RA CO. LTD.; 1850-3 hirookanomura; shiojiri, nagano 399-0 702; JA 399-0702
• Manufacturer Contact: nancy gould ; 577 aptakisic rd; lincolnshire, il ; 5439678
• MDR Report Key: 9825241
• MDR Text Key: 203143688
• Report Number: 1000515253-2020-00011
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/12/2020

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: Other
• Device Model Number: CF-70
• Device Catalogue Number: AH699752
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2020
• Initial Date FDA Received: 03/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2019
• 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