FDA Adverse Event Malfunction Summary report: N

COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

MDR report key: 3791580 · Received May 6, 2014

Report

Report Number: 1061932-2014-00921
Event Type: Malfunction
Date Received: May 6, 2014
Date of Event: April 7, 2014
Report Date: April 7, 2014
Manufacturer: BECKMAN COULTER
Product Code: GKZ
PMA / PMN Number: K010765
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

A CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING OVER THE TELEPHONE. THE CUSTOMER REPORTED THAT ONE OF THE I-BEAM TUBING WAS LEAKING AND THE CUSTOMER WAS UNABLE TO IDENTIFY THE EXACT TUBING WHICH WAS LEAKING. THE CUSTOMER WAS COMFORTABLE WITH REPLACING THE TUBING AT PINCH VALVE PV49 TO RESOLVE THE LEAK AND WOULD CALL BACK IF FURTHER ASSISTANCE WAS NEEDED. THE CUSTOMER HAS NOT CALLED BACK AS OF (B)(4) 2014 AND A FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED TO THE CUSTOMER'S SITE. IN CONCLUSION, FAILURE MODE OF THE EVENT IS ATTRIBUTED TO TUBING AT PINCH VALVE PV49. (B)(4).

Description of Event or Problem · 1

THE CUSTOMER REPORTED A LEAK OF APPROXIMATELY 5 MILLILITERS OF DILUENT FROM THE PINCH VALVE (PV49) OF THE COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER, DURING STARTUP WHILE RUNNING LATRON PRIMER AND CONTROL. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LABORATORY COAT AND GLOVES AT THE TIME OF THE EVENT AND THERE WAS NO REPORT OF INJURY OR DIRECT EXPOSURE TO THE LEAK. ERRONEOUS PATIENT RESULTS WERE NOT GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
270816	COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER	COUNTER, DIFFERENTIAL CELL	GKZ	BECKMAN COULTER	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1