MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-08-08 for BACTEC 9240 SYSTEM 445475 manufactured by Bd Diagnostic Systems.
[21290959]
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.
Patient Sequence No: 1, Text Type: D, B5
[21357903]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119779-2012-00007 |
| MDR Report Key | 2696350 |
| Report Source | 05 |
| Date Received | 2012-08-08 |
| Date of Report | 2012-07-17 |
| Date of Event | 2012-07-17 |
| Date Mfgr Received | 2012-07-17 |
| Device Manufacturer Date | 2005-08-01 |
| Date Added to Maude | 2012-08-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | GAIL CLAIBORNE |
| Manufacturer Street | 7 LOVETON CIR. |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164054 |
| Manufacturer G1 | BD DIAGNOSTIC SYSTEMS |
| Manufacturer Street | 7 LOVETON CIR. |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 21152 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACTEC 9240 SYSTEM |
| Product Code | JTA |
| Date Received | 2012-08-08 |
| Returned To Mfg | 2012-08-02 |
| Model Number | 9240 |
| Catalog Number | 445475 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD DIAGNOSTIC SYSTEMS |
| Manufacturer Address | SPARKS MD 21152 US 21152 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-08-08 |