FDA Adverse Event Malfunction Summary report: N

CYTOMICS FC 500 FLOW CYTOMETER SYSTEM

MDR report key: 3882558 · Received June 19, 2014

Report

Report Number: 1061932-2014-01368
Event Type: Malfunction
Date Received: June 19, 2014
Date of Event: May 26, 2014
Report Date: May 26, 2014
Manufacturer: BECKMAN COULTER
Product Code: GKZ
PMA / PMN Number: K071681
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SF
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND REPLACED THE WASTE PUMP HEAD, AND CLEANED AND REPLACED WASTE TUBING TO RESOLVE THE ISSUE. THE FSE THEN VERIFIED THE REPAIR AS PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED SPECIFICATIONS. THE CAUSE OF THE EVENT IS ATTRIBUTED TO A BROKEN WASTE PUMP TUBING. (B)(4).

Description of Event or Problem · 1

WHILE AT THE CUSTOMER'S SITE TO SERVICE A DIFFERENT INSTRUMENT, THE FIELD SERVICE ENGINEER (FSE) WAS NOTIFIED BY THE CUSTOMER OF A LEAK FROM THE CYTOMICS FC 500 FLOW CYTOMETER SYSTEM AS A RESULT OF A BROKEN WASTE PUMP TUBING. THE FSE REPORTED THAT APPROXIMATELY 250 MILLILITERS OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) PREPARED SAMPLE LEAKED AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE FSE PROCEEDED TO CLEAN THE SPILL AND DISINFECTED THE WORK PLACE. THE FSE WORE PERSONAL PROTECTIVE EQUIPMENT 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 FOR THIS EVENT. THE PREPARED SAMPLE PLATE WAS DISCARDED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
362070	CYTOMICS FC 500 FLOW CYTOMETER SYSTEM	COUNTER, DIFFERENTIAL CELL	GKZ	BECKMAN COULTER	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1