FDA Adverse Event Malfunction Summary report: N

COULTER® ACT DIFF ANALYZER

MDR report key: 2955766 · Received February 11, 2013

Report

Report Number: 1061932-2013-00170
Event Type: Malfunction
Date Received: February 11, 2013
Date of Event: January 17, 2013
Report Date: January 17, 2013
Manufacturer: BECKMAN COULTER
Product Code: GKZ
PMA / PMN Number: K973634
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

BLOOD, CONTROLS, CLENZ, OR DILUENT MAY HAVE BEEN LEAKED FROM THE PROBE OR PROBE ASSEMBLY. THE CUSTOMER TRIED TO FLUSH BLEACH AND WATER THROUGH THE LINES, BUT IT SEEMED THERE WAS A CLOT IN THE LINE. A SERVICE CALL WAS GENERATED. A BEC FIELD SERVICE ENGINEER (FSE) HAD THE CUSTOMER FLUSH OUT VALVE VL8 TO UNPLUG THE DRAIN PATH FROM THE PROBE WIPE TO THE VACUUM CHAMBER RESOLVING THE PROBE DRIP. FAILURE MODE OF THIS EVENT WAS PLUGGED VALVE VL8. (B)(4).

Description of Event or Problem · 1

A CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT THE PROBE ON THEIR COULTER ACT DIFF ANALYZER LEAKED MORE THAN 1ML OF DILUENT MIXED WITH BLOOD THAT SOAKED A PAPER TOWEL. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), CONSISTING OF GLOVES, A GOWN, AND GLASSES. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THE CUSTOMER HAS AN EXPOSURE CONTROL PLAN IN PLACE. PER THE CUSTOMER, THEY RAN CONTROLS IN THE MORNING AND AFTER THEY TESTED PATIENT SAMPLES WHICH THEY HAVE NOT BEEN AFFECTED. THE CUSTOMER INDICATED THAT THE LEAK STARTED IN THE AFTERNOON. NEITHER DEATH NOR INJURY WAS REPORTED IN CONNECTION TO THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
59679	COULTER® ACT DIFF ANALYZER	COUNTER, DIFFERENTIAL CELL	GKZ	BECKMAN COULTER		NA

Patients

Seq	Age	Sex	Outcome	Treatment
1