FDA.reportPublic FDA data

MAUDE MDR 2001977

MDR report key
2001977
Report number
1061932-2011-00104
Event key
0
Event type
3
Date of event
2011-01-26
Date received
2011-02-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MS NORA ZEROUNIAN
Address
250 S KRAEMER BOULEVARD BREA CA 92821 US
Phone
714-714-7149
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1COULTER LH 750 ANALYZERAUTOMATED DIFFERENTIAL CELL COUNTERBECKMAN COULTER, INC.LOQLH 7506605632N/AY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-02-270

Event Narratives#

D

Patient 1

A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE COULTER LH 750 ANALYZER WAS LEAKING BLOODY FLUID CONTAINED INSIDE THE UNIT. THERE WAS NO DEATH, INJURY, OR AFFECT TO PATIENT TREATMENT. THERE WAS NO CONTACT WITH SKIN, EYES, MUCOUS MEMBRANES, OR OPEN LESIONS AS THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. NO MEDICAL TREATMENT WAS SOUGHT BY THE OPERATOR.

N

Patient 1

A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 FOR THIS EVENT. THE FSE REPLACED THE PINCH VALVE (PV) WHICH WAS CRACKED, ALL ASPIRATION TUBING TO THE REAR BLOOD DETECTOR, AND THE SHEAR VALVE WHICH WAS LEAKING. THE FSE ALSO REPLACED THE FRONT BLOOD DETECTOR AND VERIFIED THE INSTRUMENTS OPERATION. THE ROOT CAUSE IS THE HARDWARE THAT WAS REPLACED DURING THE SUBSEQUENT INSTRUMENT SERVICING FOR THIS EVENT. PER LABELING, BECKMAN COULTER, INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER.