FDA.reportPublic FDA data

MAUDE MDR 2696350

MDR report key
2696350
Report number
1119779-2012-00007
Event key
0
Event type
3
Date of event
2012-07-17
Date received
2012-08-08
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
GAIL CLAIBORNE
Address
7 LOVETON CIR. SPARKS MD 21152 US
Phone
410-410-4103
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BACTEC 9240 SYSTEMBD DIAGNOSTIC SYSTEMSJTA9240445475Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-08-0801. O

Event Narratives#

D

Patient 1

BD WAS ON SITE TO RELOCATE THREE BACTEC 9240 INSTRUMENTS FROM ONE AREA IN THE LAB TO ANOTHER. MOVERS RELOCATED INSTRUMENT 2 INTO THE LOWER PORTION OF A DOUBLE STAND AND INSTRUMENT 3 INTO THE TOP PORTION OF THE STAND. INSTRUMENTS WERE PLUGGED IN AND MOVERS WENT TO MOVE INSTRUMENT 1. WHILE WORKING ON INSTRUMENT 1, LAB TECHNICIANS INFORMED THE ENGINEERS THAT INSTRUMENT 3, SERIAL NUMBER (B)(4), WAS ON FIRE. INSTRUMENT WAS IMMEDIATELY UNPLUGGED FROM POWER, THE ELECTRICAL PANEL OPENED AND THE FIRE EXTINGUISHED. SMOKE FILLED THE LAB, BUT NO EVACUATION WAS REQUIRED. NO INJURIES OCCURRED. SOOT/SMOKE DAMAGE WAS EVIDENT ON THE WALL OF THE FACILITY AND THE INSTRUMENT. THE REMAINING INSTRUMENT WAS MOVED WITHOUT INCIDENT. BD ENGINEER ON SITE CALLED TO REPORT THIS EVENT.

N

Patient 1

INSTRUMENT SERIAL NUMBER (B)(4) WAS INSTALLED AT CUSTOMER SITE ON (B)(4) 2005 AND HAS RUN WITHOUT ISSUE UNTIL THIS EVENT. THE FIRE OCCURRED AFTER THE INSTRUMENTS WERE MOVED TO ANOTHER LOCATION WITHIN THE FACILITY. QUALITY EXAMINED THE RETURNED INSTRUMENT AND DETERMINED THE SOURCE OF THE FIRE TO BE THE ELECTRICAL INTERFACE BETWEEN THE INSTRUMENT AND THE POWER SOURCE AT THE CUSTOMER SITE. THIS IS SUPPORTED BY EVIDENCE OF EXTREME HEAT THAT MELTED THE PLUG/RECEPTACLE ON THE INSTRUMENT. THE INTERNAL CIRCUITRY OF THE INSTRUMENT WAS NOT AFFECTED PROVIDING ADDITIONAL EVIDENCE TO THE SOURCE OF THE FIRE. THE MOST PROBABLE ROOT CAUSE OF THE FIRE IS AN INTERFACE PROBLEM BETWEEN THE LINE CORD AND LINE FILTER (THIS IS THE RECEPTACLE ON THE INSTRUMENT). THIS COULD BE CAUSED BY A CORRODED CORD OR THAT THE CORD WAS MECHANICALLY LOOSE. BOTH SCENARIOS CAN RESULT IN AN ARC WHICH COULD CAUSE THE LEADS TO MELT AND SUBSEQUENT FIRE. TYPICALLY WHEN AN ARC OCCURS, THE CIRCUIT BREAKER (FROM THE POWER SOURCE) WOULD TRIP AND POWER WOULD BE CUT TO THE INSTRUMENT THEREBY REDUCING THE RISK OF FIRE. THE CUSTOMER EITHER FAILED TO HAVE A CIRCUIT BREAKER ON THE POWER SUPPLY OR THE BREAKER DID NOT FUNCTION AS INTENDED. THE INSTRUMENT SPECIFICATIONS RECOMMEND THE INSTALLATION OF AN EMERGENCY POWER LINE AND THE PROPER POWER REQUIREMENTS FOR THE INSTRUMENT TO OPERATE. THE EXACT CAUSE FOR THIS INCIDENT COULD NOT BE DETERMINED DUE TO THE DAMAGE TO THE INSTRUMENT. THIS IS AN ISOLATED INCIDENT. THERE ARE CURRENTLY NO TRENDS FOR THIS FAILURE MODE. NO CORRECTIVE ACTIONS WILL BE PERFORMED AT THIS TIME. QUALITY WILL CONTINUE TO CLOSELY MONITOR THIS TYPE OF FAILURE.