FDA Adverse Event Malfunction Summary report: N

COULTER® LH 750 SLIDEMAKER

MDR report key: 2110104 · Received June 1, 2011

Report

Report Number: 1061932-2011-00521
Event Type: Malfunction
Date Received: June 1, 2011
Date of Event: May 2, 2011
Report Date: May 2, 2011
Manufacturer: BECKMAN COULTER, INC.
Product Code: GKJ
PMA / PMN Number: CL1 EXEMPT
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CT, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

SERVICE WAS PROVIDED AND THE FIELD SERVICE ENGINEER (FSE) DISCOVERED A SLIDE JAMMING THE SHUTTLE AND NOT ALLOWING THE SLIDE TO BE UNDER THE PROBE CORRECTLY. THE SLIDE WAS REMOVED INTACT. IN ADDITION, THE VACUUM ERROR WAS CAUSED BY THE SENSOR GETTING WET. SUBSEQUENTLY THE SENSOR WAS REPLACED. REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES AND THE RESULTS MEET PUBLISHED PERFORMANCE SPECIFICATIONS. ROOT CAUSE FOR THE BLOOD SPILL WAS ASSOCIATED WITH ONE JAMMED SLIDE ON THE SHUTTLE CAUSING SENSOR ERROR DUE TO THE ENCLOSED SURROUNDING MOISTURE.

Description of Event or Problem · 1

A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) AND REPORTED A BLOOD SPILL IN THE COULTER LH750 SLIDEMAKER FOLLOWED BY VACUUM SENSOR ERRORS. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT AND THE SPILL WAS CLEANED UP ACCORDING TO THE DEFINED LABORATORY PROTOCOL. THE FACILITY HAS AN EXPOSURE PLAN. MSDS WAS NOT REVIEWED BUT READILY AVAILABLE. THERE WAS NO REPORT OF BLOOD EXPOSURE TO MUCOUS MEMBRANES, EYES, MOUTH, OR OPEN WOUNDS. THERE WAS NO REPORT OF INJURY AND NO ONE SOUGHT MEDICAL ATTENTION. THERE WAS NO DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	COULTER® LH 750 SLIDEMAKER	AUTOMATED SLIDE SPINNER	GKJ	BECKMAN COULTER, INC.	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1