FDA Adverse Event Malfunction Summary report: N

COULTER LH 500 HEMATOLOGY ANALYZER

MDR report key: 3895550 · Received June 25, 2014

Report

Report Number: 1061932-2014-01449
Event Type: Malfunction
Date Received: June 25, 2014
Date of Event: June 1, 2014
Report Date: June 1, 2014
Manufacturer: BECKMAN COULTER
Product Code: GKZ
PMA / PMN Number: K042724
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, 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 OBSERVED A PINHOLE LEAK FROM THE PELTIER MODULE TUBE FITTING THROUGH FEED-THRU-FITTING FF175. THE FSE ALSO OBSERVED A LEAK FROM THE PELTIER MODULE TUBE FITTING OF THE TUBING CONNECTED TO PORT 6 OF THE BLOOD SAMPLING VALVE (BSV) DUE TO UNFASTENED TUBING ON THE FITTING. THE FSE REPLACED THE TUBING THROUGH FF175 AND THE TUBING CONNECTED TO PORT 6 OF THE BSV TO RESOLVE THE LEAK ISSUE AND THE AMBIENT TEMPERATURE ERROR. THE FSE VERIFIED THE INSTRUMENT AND THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. (B)(4).

Description of Event or Problem · 1

THE CUSTOMER REPORTED APPROXIMATELY 10 TO 20 MILLILITERS OF CLEAR FLUID LEAKED FROM THE FRONT OF THE COULTER LH 500 HEMATOLOGY ANALYZER AND AMBIENT TEMPERATURE ERROR FOR THE LYSE WAS GENERATED. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LAB COAT AT THE TIME OF THE OCCURRENCE. THERE WAS NO EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION WITH THE REPORTED EVENT. THERE WAS NO DEATH, INJURY, OR AFFECT TO USER OR TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
370715	COULTER LH 500 HEMATOLOGY ANALYZER	COUNTER, DIFFERENTIAL CELL	GKZ	BECKMAN COULTER	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1