FDA.reportPublic FDA data

MAUDE MDR 9740828

MDR report key
9740828
Report number
1000515253-2020-00004
Event key
0
Event type
3
Date of event
2020-01-09
Date received
2020-02-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MRS. NANCY GOULD
Address
577 APTAKISIC RD LINCOLNSHIRE, IL US
Phone
543-543-5439
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SYSMEX TS-10AUTOMATED TUBE SORTERSYSMEX RA CO. LTD.LXGTS-10BN168792Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-210

Event Narratives#

N

Patient 1

THE TS-10 INSTRUCTIONS FOR USE WARN THE USER IN CHAPTER 2 - SAFETY INFORMATION, SECTION 2.1 - GENERAL INFORMATION: "IN THE UNLIKELY EVENT THAT THE SYSTEM EMITS AN UNUSUAL ODOR OR SMOKE, IMMEDIATELY TURN OFF THE MAIN SWITCH AND UNPLUG THE POWER CABLE. THEN CONTACT YOUR SYSMEX SERVICE REPRESENTATIVE. CONTINUED USE OF THE SYSTEM IN SUCH CONDITIONS COULD RESULT IN FIRE, ELECTRICAL SHOCK OR PERSONAL INJURY." THE FUSE HOLDER IS LOCATED IN THE CONTROL DEVICE AND NOT READILY ACCESSIBLE TO THE USER. FURTHERMORE, THE FUSE HOLDERS ARE MADE OF FLAME RESISTANT MATERIAL, REDUCING POTENTIAL FOR COMBUSTION. INVESTIGATION BY SYSMEX CORPORATION (B)(4) (S-CORP) IS IN PROCESS.

D

Patient 1

A SYSMEX TECHNICAL PRODUCT MANAGER (TPM) IN GERMANY NOTED A BURNT PLASTIC ODOR EMANATING FROM THE TS-10 TUBE SORTER AFTER AN ARM ERROR HAD OCCURRED. THE TPM FOUND THE FUSE HOLDER IN THE CONTROL DEVICE BURNT. THERE WAS NO REPORT OF HARM TO THE OPERATOR OR NEGATIVE IMPACT TO PATIENT MANAGEMENT.