FDA Adverse Event Malfunction Summary report: N

COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

MDR report key: 3840023 · Received May 30, 2014

Report

Report Number: 1061932-2014-01129
Event Type: Malfunction
Date Received: May 30, 2014
Date of Event: April 30, 2014
Report Date: April 30, 2014
Manufacturer: BECKMAN COULTER
Product Code: GKZ
PMA / PMN Number: K010765
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT. THE FSE FOUND THE BLOOD DETECTOR CAME OFF THE WALL OF THE UNIT AND WAS PROHIBITING MOVEMENT OF THE PROBE WHICH MADE THE PROBE WASH LEAK DILUENT DURING PROBE CLEANING. THE FSE REPLACED THE BLOOD DETECTOR TO FREE UP THE PROBE. THE FSE ALSO NOTED THAT 60 PSI WAS LOW. THE FSE ADJUSTED 60 PSI AND VERIFIED OPERATION. THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. (B)(4).

Description of Event or Problem · 1

THE CUSTOMER REPORTED THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER LEAKED ABOUT 5 CC OF FLUID AROUND THE BLOOD SAMPLING VALVE (BSV) DURING START-UP CYCLE. THE CUSTOMER STATED THE DIFFERENTIAL (DIFF) BACKGROUND WAS FAILING AND THE INSTRUMENT WAS GIVING COMPRESSOR PRESSURE ERROR. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THERE WAS NO EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) INCLUDED LAB COAT AND GLOVES. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION WITH THE REPORTED EVENT. THERE WAS NO DEATH, INJURY, OF AFFECT TO USER OR TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
319071	COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER	COUNTER, DIFFERENTIAL CELL	GKZ	BECKMAN COULTER	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1