FDA Adverse Event Malfunction Summary report: N

COULTER® LH 750 HEMATOLOGY ANALYZER

MDR report key: 3250802 · Received July 29, 2013

Report

Report Number: 1061932-2013-01544
Event Type: Malfunction
Date Received: July 29, 2013
Date of Event: July 6, 2013
Report Date: July 6, 2013
Manufacturer: BECKMAN COULTER
Product Code: GKZ
PMA / PMN Number: K011342
Removal / Correction Number: N/A
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE ON 07/07/2013. THE FSE INSPECTED THE INSTRUMENT AND REPLACED SPLIT YELLOW STRIPE TUBING THROUGH PINCH VALVE (VL12D) TO OUTLET OF WASTE CHAMBER (VC14), RESOLVING THE LEAK. THE FSE ALSO PERFORMED AN INCIDENTAL SERVICES ADJUSTING THE LOW VACUUM. FAILURE MODE WAS ATTRIBUTED TO TUBING THROUGH VL12D. BECKMAN INTERNAL IDENTIFIER NUMBER FOR THIS REPORT IS (B)(4).

Description of Event or Problem · 1

THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT ABOUT 50 ML OF BLOOD AND DILUENT LEAKED FROM THE COULTER LH 750 HEMATOLOGY ANALYZER WHITE BLOOD CELL (WBC) BATH AND ONTO THE COUNTER. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THERE WERE NO ALARMS (SYSTEM ALERTS) ASSOCIATED WITH THIS EVENT. THERE IS AN EXPOSURE CONTROL PLAN AT THE FACILITY. THE CUSTOMER WAS WEARING GLOVES, A LABORATORY COAT, AND EYE GLASSES AT THE TIME OF THIS EVENT. THERE WAS NO DIRECT PHYSICAL CONTACT WITH THE FLUID. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. THE LEAK DID NOT AFFECT ANY PATIENT RESULTS NOR WERE ANY RESULTS GENERATED OR REPORTED OUT OF THE LABORATORY, THEREFORE PATIENT TREATMENT WAS NOT IMPACTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
354188	COULTER® LH 750 HEMATOLOGY ANALYZER	COUNTER, DIFFERENTIAL CELL	GKZ	BECKMAN COULTER	LH 750	N/A

Patients

Seq	Age	Sex	Outcome	Treatment
1